CLASS I Device recall · Reported 27 Jan 2016 · FDA Enforcement Report
Cranial Navigation System: An Image Guided Surgery System recalled
Brainlab AG is recalling Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic, distributed nationwide in the US. The recall was initiated on 22 Apr 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0598-2016
- FDA event ID
- 71924
- Recalling firm
- Brainlab AG, Munich, N/A
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 22 Apr 2013
- FDA classified
- 19 Jan 2016
- Reported
- 27 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 22 Apr 2013 | Recall initiated by company | |
| 19 Jan 2016 | Classified by FDA | +1002 days |
| 27 Jan 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
Product as listed by the FDA
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
Where it was distributed
Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
Questions about this recall
Is Cranial Navigation System: An Image Guided Surgery System / Stereotactic recalled?
Yes. Brainlab AG recalled Cranial Navigation System: An Image Guided Surgery System / Stereotactic on 22 Apr 2013. The recall is Class I and its status is Terminated. Recall number Z-0598-2016.
Why was it recalled?
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
Which lots are affected?
1) Model 22035 , VVC NAVIGATION SOFTWARE CRANIAL 5.0 , Serial Numbers: 22035-103911-004 , 22035-103953-001 , 22035-103977-001 , 22035-103982-002 , 22035-103987-001 , 22035-103988-001 , 22035-104566-001 ; 2) Model 22040 , VV NAVIGATION SOFTWARE CRANIAL 4.0 , Serial Numbers: 22040/18820 , 22040/21370 , 22040/26909 , 22040/36997 , 22040-103675-006 , 22040-103687-009 , 22040-103710-001 , 22040-103942-008 , 22040-103974-011 , 22040-104067-001 , 22040-104072-001 , 22040-104114-001 , 22040-104148-001 , 22040-104151-001 , 22040-104505-001 , 22040-104542-001 , 22040-104545-001 , 22040-104614-005 , 22040-123772-001 ; 3) Model 22040-02 , VV NAV SW CRANIAL 7.8.1 (ANY PLATFORM) , Serial Number: 000000002600509001 ; 4) Model 22040-11 , UPDATE VV NAV SW CRANIAL 7.9.1 FROM 7.9 , Serial Numbers: 000000007665811001 , 000000007801111004 , 000000007801111005 , 000000007801111006 , 000000007801111007 , 000000007801111008 , 000000007801111009 , 000000007808711004 , 000000007808711007 , 000000007808711008 , 000000007837611010 , 000000007847411007 , 000000007865211004 , 000000007865211005 , 000000007942211004 , 000000007942211008 , 000000007942211010 , 000000007950411001 , 000000007950411004 , 000000007950411007 , 000000007950411010 , 000000007956611005 , 000000007956611010 , 000000007956611017 , 000000007965011001 , 000000007965011006 , 000000007965011007 , 000000007980111001 , 000000007980111002 , 000000007980111003 , 000000007980111004 , 000000007980111005 , 000000007980111006 , 000000007980111007 , 000000008000111003 , 000000008000111006 , 000000008000111007 , 000000008012411001 , 000000008012411003 , 000000008012411008 , 000000008026011002 , 000000008026011003 , 000000008036811002 , 000000008036811006 , 000000008036811007 , 000000008036811008 , 000000008036911002 , 000000008036911004 , 000000008036911005 , 000000008046111002 , 000000008046111005 , 000000008073511003 , 000000008073511007 , 000000008086811001 , 000000008106711001 , 000000008114111004 , 000000008129711004 , 000000008129711005 , 000000008129711006 , 000000008133311001 , 000000008133311002 , 000000008143111002 , 000000008143111003 , 000000008143111004 , 000000008157411005 , 000000008157411007 , 000000008167811005 , 000000008167811008 , 000000008167811012 , 000000008167811014 , 000000008167811015 , 000000008167811016 , 000000008180811001 , 000000008180811008 , 000000008180811009 , 000000008180811010 , 000000008180811011 , 000000008181011002 , 000000008208411002 , 000000008230111001 , 000000008230111002 , 000000008230111009 , 000000008230111013 , 000000008230111015 , 000000008230111022 , 000000008230111024 , 000000008230111025 , 000000008230211001 , 000000008230211002 , 000000008230211008 , 000000008230211017 , 000000008230211020 , 000000008230211025 , 000000008230211030 , 000000008230311006 , 000000008230311014 , 000000008230311015 , 000000008230311018 , 000000008230411003 , 000000008230411005 , 000000008230411009 , 000000008230411010 , 000000008230411012 , 000000008230411016 , 000000008230411021 , 000000008230411024 , 000000008230411029 , 000000008230411030 , 000000008230411031 , 000000008230411032 , 000000008242111002 , 000000008242111003 , 000000008242111005 , 000000008242611001 , 000000008242611002 , 000000009168012001 ; 5) Model 22040B , VV NAVIGATION SOFTWARE CRANIAL7.5.0 , Serial Numbers: 05-48916-22040B , 05-51803-22040B , 05-52149-22040B , 22040B/46911 ; 6) Model 22040C , VV NAVIGATION SOFTWARE CRANIAL 7.6.0 , Serial Numbers: 05-63659-22040C , 05-63669-22040C , 05-66754-22040C , 06-79914-22040C ; 7) Model 22040D , VV NAVIGATION SW CRANIAL 7.7 , Serial Numbers: 06-84302-22040D , 06-85635-22040D , 06-88801-22040D ; 8) Model 22040E , VV NAVIGATION SW CRANIAL 7.8 , Serial Numbers: 06-101594-22040E , 06-103819-22040E , 06-108132-22040E , 07-102189-22040E , 07-106354-22040E , 07-108464-22040E , 07-109071-22040E , 07-109217-22040E , 07-110114-22040E , 07-112255-22040E , 07-112347-22040E , 07-113858-22040E , 07-114331-22040E , 07-117343-22040E , 07-118687-22040E , 07-118695-22040E , 07-119019-22040E , 07-119599-22040E , 07-120231-22040E , 07-120842-22040E , 07-122228-22040E , 07-123321-22040E , 07-124014-22040E , 07-126723-22040E , 07-128644-22040E , 07-129197-22040E , 07-129354-22040E , 07-130356-22040E ; 9) Model 22040F , VV NAVIGATION SW CRANIAL 7.8.1 , Serial Numbers: 000000001242908001 , 000000001275408001 , 000000001305408001 , 000000001346908001 , 000000001386608001 , 000000001402808001 , 000000001506308001 , 000000001516208001 , 000000001548508001 , 000000001611208001 , 000000001644608001 , 000000001716308001 , 000000001730608001 , 000000001832508001 , 000000001832608001 , 000000001867508001 , 000000001869408001 , 000000001924908001 , 000000001943208001 , 000000001944708001 , 000000002054708001 , 000000002082108001 , 000000002179709001 , 000000002352209001 , 000000002401209001 , 000000002540709001 , 000000002540809001 , 000000002565609001 , 000000002565809001 , 000000002610309001 , 000000002921409001 , 000000002945709001 , 000000003057109001 , 000000003171909001 , 000000003331709001 , 000000003433809001 , 000000003446909001 , 3540908001 , 3557608001 , 6039008001 , 6110908001 , 6303008001 , 6406408001 , 6594408001 , 6655308001 , 6757308001 , 6983608001 , 07-133796-22040F , 07-134724-22040F , 07-135062-22040F , 07-135413-22040F , 07-136068-22040F , 07-136871-22040F , 07-137864-22040F , 07-138500-22040F , 07-138954-22040F , 07-138987-22040F , 07-139009-22040F , 07-139027-22040F , 07-139037-22040F , 07-139083-22040F , 07-139412-22040F , 07-139955-22040F , 07-141837-22040F , 07-144111-22040F , 07-145211-22040F , 07-146009-22040F , 08-148434-22040F , 08-149705-22040F , 08-153066-22040F , 08-154083-22040F , 08-155770-22040F , 08-156023-22040F , 08-156226-22040F , 08-156570-22040F , 08-157148-22040F , 08-157972-22040F ; 10) Model 22040H , VV NAVIGATION SW CRANIAL 7.9.1 , Serial Numbers: 000000004274913001 , 000000008413811001 ; 11) Model 22043 , UPDATE VV NAV SWCRANIAL 6.0 TO 6.01 , Serial Numbers: 07-135238-22043 , 22043/1194 ; 12) Model 22204-02 , KOLIBRI NAV SW CRAN 2.6.1 (ANY PLATFORM) , Serial Number: 000000003102809001 ; 13) Model 22204B , KOLIBRI NAVIGATION SW CRANIAL 2.5.0 , Serial Number: 06-86477-22204B ; 14) Model 22204C , KOLIBRI NAVIGATION SW CRANIAL 2.6.0 , Serial Numbers: 06-100679-22204C , 06-104941-22204C , 07-112890-22204C , 07-114630-22204C , 07-116967-22204C , 07-123214-22204C , 07-128684-22204C , 07-129055-22204C , 07-133191-22204C , 07-133265-22204C , 15) Model 22204D , KOLIBRI NAVIGATION SW CRANIAL 2.6.1 , Serial Numbers: 000000001120208001 , 000000001125508001 , 000000001178108001 , 000000001291308001 , 000000001343608001 , 000000001362808001 , 000000001671208001 , 000000002019108001 , 000000002108909001 , 000000002219709001 , 000000002308509001 , 000000002494309001 , 6259008001 , 6381208001 , 6662908001 , 6898208001 , 07-134523-22204D , 07-135013-22204D , 07-135592-22204D , 07-141778-22204D , 07-142020-22204D , 07-149290-22204D , 08-148598-22204D , 08-152171-22204D , 08-153392-22204D , 08-153694-22204D , 08-154014-22204D , 08-154473-22204D , 08-157303-22204D , 08-157669-22204D ; 16) Model 22204E , KOLIBRI NAVIGATION SW CRANIAL 2.7 , Serial Number: 000000003211909001 ; 17) Model 22207 , CRANIAL ESSENTIAL NAV SW 1.0 , Serial Numbers: 000000002787409001 , 000000002796409001 , 000000002811509001 , 000000002867009001 , 000000002906409001 , 000000002930409001 , 000000003058009001 , 000000003220409001 , 000000003224109001 , 000000003546309001 , 000000003576409001 , 000000003680909001 , 000000003738509001 , 000000003982409001 , 000000003990809001 , 000000004154809001 , 000000004494710001 , 000000004535510001 , 000000004622210001 , 000000004636910001 , 000000004804710001 , 000000004910010001 , 000000004923210001 , 000000005074410001 , 000000005078110001 , 000000005100710001 , 000000005153810001 , 000000005353810001 , 000000005354110001 , 000000005427710001 , 000000005453410001 , 000000005607210001 , 000000005651510001 , 000000005668710001 , 000000005710010001 , 000000005736910001 , 000000005838110001 , 000000006077510001 , 000000006148710001 , 000000006179010001 , 000000006306910001 , 000000006339910001 , 000000006363010001 , 000000006726411001 , 000000006949311001 , 000000007053911001 , 000000007076211001 , 000000007146511001 , 000000007172711001 , 000000007302311001 , 000000007418911001 ; 18) Model 22207A , CRANIAL ESSENTIAL NAVIGATION SW 1.0.1 , Serial Number: 000000007678411001 ; 19) Model 22208 , CRANIAL UNLIMITED NAV SW 1.0 , Serial Numbers: 000000002958709001 , 000000003668009001 , 000000004574810001 , 000000004694310001 , 000000005096210001 , 000000005278010001 , 000000005728710001 , 000000006119610002 , 000000006119610003 , 000000006119610004 , 000000006119610005 , 000000006271410001 , 000000006654910001 , 000000006694611001 , 000000006786911001 ; 20) Model 22208-11 , UPDATE CRANIAL UNLIMITED 1.0.1 FROM 1.0 , Serial Numbers: 000000007719311001 , 000000007757911001 , 000000007775111001 , 000000007801311002 , 000000007801311005 , 000000007808811004 , 000000007814811001 , 000000007814811002 , 000000007830611001 , 000000007830611003 , 000000007837811001 , 000000007837811003 , 000000007837811004 , 000000007847611002 , 000000007856311001 , 000000007856311003 , 000000007856311005 , 000000007856311006 , 000000007865011004 , 000000007865011005 , 000000007865011006 , 000000007891211001 , 000000007891211002 , 000000007891211003 , 000000007891211004 , 000000007891211005 , 000000007927911001 , 000000007927911002 , 000000007927911003 , 000000007927911005 , 000000007927911009 , 000000007928011001 , 000000007928011002 , 000000007928011003 , 000000007942511002 , 000000007942511003 , 000000007942511005 , 000000007942511006 , 000000007942511013 , 000000007942511014 , 000000007942511016 , 000000007942511018 , 000000007950711002 , 000000007950711004 , 000000007950711005 , 000000007950711009 , 000000007950711011 , 000000007957111012 , 000000007980311001 , 000000007980311002 , 000000007980311004 , 000000007980311006 , 000000007980311010 , 000000007980311011 , 000000007980311012 , 000000008012711002 , 000000008012711004 , 000000008025711001 , 000000008025711002 , 000000008025711003 , 000000008037311001 , 000000008037411001 , 000000008037411002 , 000000008037411003 , 000000008037411005 , 000000008045711002 , 000000008045711004 , 000000008059111001 , 000000008059211001 , 000000008074511004 , 000000008074511006 , 000000008074511008 , 000000008074511009 , 000000008074511011 , 000000008074511013 , 000000008074511014 , 000000008074511016 , 000000008074611001 , 000000008074611002 , 000000008087011002 , 000000008087011004 , 000000008087011008 , 000000008087011009 , 000000008087011010 , 000000008087011011 , 000000008087211001 , 000000008106811001 , 000000008106811003 , 000000008106811004 , 000000008114411002 , 000000008114411005 , 000000008114411009 , 000000008114411012 , 000000008129911003 , 000000008129911004 , 000000008129911005 , 000000008129911006 , 000000008129911007 , 000000008129911008 , 000000008134911002 , 000000008134911003 , 000000008134911004 , 000000008134911005 , 000000008134911006 , 000000008134911007 , 000000008134911008 , 000000008134911009 , 000000008134911010 , 000000008134911011 , 000000008134911016 , 000000008143611001 , 000000008143611002 , 000000008143611004 , 000000008143611006 , 000000008143611007 , 000000008143611008 , 000000008143611010 , 000000008143611011 , 000000008143611012 , 000000008143611016 , 000000008143611018 , 000000008143611019 , 000000008143611020 , 000000008143611024 , 000000008143611026 , 000000008143611027 , 000000008150011001 , 000000008150011003 , 000000008150011004 , 000000008150011005 , 000000008150011006 , 000000008157811001 , 000000008157811002 , 000000008157811003 , 000000008157811007 , 000000008157811008 , 000000008157811009 , 000000008157811010 , 000000008157811012 , 000000008168311002 , 000000008168311005 , 000000008168311006 , 000000008168311007 , 000000008168311008 , 000000008168311009 , 000000008168311010 , 000000008168311011 , 000000008181511003 , 000000008181511004 , 000000008208911001 , 000000008208911004 , 000000008208911005 , 000000008222511001 , 000000008222511002 , 000000008222511003 , 000000008222511005 , 000000008222511006 , 000000008222511008 , 000000008222511009 , 000000008222511010 , 000000008222511011 , 000000008222511013 , 000000008222511014 , 000000008230711001 , 000000008230711004 , 000000008230711005 , 000000008230711006 , 000000008230711007 , 000000008230711008 , 000000008242711001 , 000000008242711005 , 000000008242711006 , 000000008242711008 , 000000008242711009 , 000000008242711010 , 000000008242711011 , 000000008242711012 , 000000008242711013 , 000000008242711015 , 000000008242711016 , 000000008242711019 , 000000008242711020 , 000000008242711023 , 000000008242711024 , 000000008242711025 , 000000008242711026 , 000000008242711027 , 000000008242711028 , 000000008242711029 , 000000008242711031 , 000000008242711033 , 000000008242711034 , 000000008242711035 , 000000008242711036 , 000000008242711038 , 000000008242711041 , 000000008242711042 , 000000008242711043 , 000000008242711044 , 000000008277511001 , 000000008352911001 , 000000009167712001 , 000000009167812001 , 000000009167912001 , 000000009239412001 , 000000009359612001 , 000000009408712001 , 000000009408812001 ; 21) Model 22208A , CRANIAL UNL NAVIGATION SW 1.0.1 , Serial Numbers: 000000001287412001 , 000000003539513001 , 000000004457713001 , 000000008293111001 , 000000008471411001 , 000000008489611001 ; 22) Model 22214 , CRANIAL NAVIGATION SW 2.1 , Serial Numbers: 000000007467211001 , 000000007489111001 , 000000007494611001 , 000000007495311001 , 000000007505911001 , 000000007516811001 , 000000007516911001 , 000000007545411001 , 000000007572811001 , 000000007576811001 , 000000007578311001 , 000000007604811001 , 000000007605711001 , 000000007605811001 , 000000007605911001 , 000000007683111001 , 000000007695511001 , 000000007735211001 , 000000007773611001 , 000000007777511001 , 000000007802011001 , 000000007840911001 , 000000007872611001 , 000000007899411001 , 000000007936111001 , 000000007954111001 , 000000007960411001 , 000000007973911001 , 000000008063011001 , 000000008067111001 , 000000008100511001 , 000000008111511001 , 000000008165111001 , 000000008189511001 , 000000008210511001 , 000000008245011001 , 000000008245111001 , 000000008260011001 , 000000008290111001 , 000000008370011001 , 000000008431811001 , 000000008441811001 ; 23) Model 22214-01 , UPDATE CRANIAL 2.1.1 FROM 2.1 , Serial Numbers: 000000008574211001 , 000000008741911001 , 000000008861011001 , 000000008980412001 , 000000009122512001 , 000000009199812001 , 000000009237012001 , 000000009283712001 , 000000009283812001 , 000000009283912001 , 000000009284012001 , 000000009284112001 , 000000009316312001 , 000000009363312001 , 000000009422712001 , 000000009437312001 , 000000009437412001 , 000000009437512001 , 000000009437612001 , 000000009481412001 , 000000009861512001 ; 24) Model 22214-01A , UPD CRANIAL 2.1.1 W/ DATA LOAD FROM 2.1 , Serial Numbers: 000000000239512001 , 000000000246112001 , 000000000605512001 , 000000000605814001 , 000000000797312001 , 000000000815712001 , 000000001221412001 , 000000001866612001 , 000000001866712001 , 000000002099012001 , 000000002698513001 , 000000004417413001 , 000000009530014001 ; 25) Model 22214-01B , UPD CRANIAL 2.1.1 W/ DATA LOAD FROM 2.1 , Serial Numbers: 000000000051714001 , 000000005104313001 , 000000006146515001 , 000000006146615001 , 000000006146715001 , 000000006146815001 , 000000007622015001 , 000000009289414001 ; 26) Model 22214A , CRANIAL NAVIGATION SW 2.1.1 , Serial Numbers: 000000000052612001 , 000000000052712001 , 000000000055912001 , 000000000157012001 , 000000008553411001 , 000000008598111001 , 000000008615711001 , 000000008624811001 , 000000008674211001 , 000000008700211001 , 000000008714811001 , 000000008715911001 , 000000008766711001 , 000000008795711001 , 000000008844011001 , 000000008848411001 , 000000008861911001 , 000000008874011001 , 000000008902511001 , 000000008947212001 , 000000008968312001 , 000000009013812001 , 000000009022712001 , 000000009043912001 , 000000009053712001 , 000000009106912001 , 000000009133112001 , 000000009133612001 , 000000009134012001 , 000000009168512001 , 000000009306012001 , 000000009342012001 , 000000009382912001 , 000000009395512001 , 000000009401412001 , 000000009461012001 , 000000009505812001 , 000000009551212001 , 000000009559212001 , 000000009573412001 , 000000009647912001 , 000000009654412001 , 000000009654612001 , 000000009745412001 , 000000009763112001 , 000000009787112001 , 000000009788212001 , 000000009816112001 , 000000009816212001 , 000000009819512001 , 000000009867212001 , 000000009885512001 , 000000009926512001 , 000000009944112001 , 000000009951112001 , 000000009964612001 ; 27) Model 22214B , CRANIAL NAVIGATION SW 2.1.1 , Serial Numbers: 000000000240112001 , 000000000240212001 , 000000000254712001 , 000000000353512001 , 000000000385712001 , 000000000385812001 , 000000000405512001 , 000000000406612001 , 000000000496312001 , 000000000503212001 , 000000000520312001 , 000000000546512001 , 000000000574812001 , 000000000587912001 , 000000000615712001 , 000000000623212001 , 000000000681112001 , 000000000709312001 , 000000000709412001 , 000000000712112001 , 000000000725312001 , 000000000726312001 , 000000000760512001 , 000000000792812001 , 000000000813012001 , 000000000848912001 , 000000000871612001 , 000000000959612001 , 000000001014212001 , 000000001132612001 , 000000001168512001 , 000000001196612001 , 000000001213712001 , 000000001235712001 , 000000001324112001 , 000000001341012001 , 000000001354912001 , 000000001362412001 , 000000001382112001 , 000000001384512001 , 000000001634612001 , 000000001634712001 , 000000001635012001 , 000000001645912001 , 000000001695412001 , 000000001705512001 , 000000001752412001 , 000000001782812001 , 000000001783612001 , 000000001804712001 , 000000001823412001 , 000000001850912001 , 000000001873512001 , 000000001882512001 , 000000001936612001 , 000000001938712001 , 000000001938812001 , 000000002045412001 , 000000002059512001 , 000000002104112001 , 000000002179412001 , 000000002240312001 , 000000002323212001 , 000000002346312001 , 000000002360212001 , 000000002368012001 , 000000002370912001 , 000000002371012001 , 000000002380812001 , 000000002401612001 , 000000002421712001 , 000000002422812001 , 000000002424312001 , 000000002433512001 , 000000002444812001 , 000000002508012001 , 000000002580412001 , 000000002610013001 , 000000002615112001 , 000000002662913001 , 000000002682613001 , 000000002705213001 , 000000002714613001 , 000000002788513001 , 000000002815713001 , 000000002967013001 , 000000002988213001 , 000000003009213001 , 000000003053413001 , 000000003059013001 , 000000003067613001 , 000000003071813001 , 000000003158813001 , 000000003223813001 , 000000003273213001 , 000000003286913001 , 000000003297813001 , 000000003300613001 , 000000003302213001 , 000000003332213001 , 000000003356613001 , 000000003379513001 , 000000003382713001 , 000000003409613001 , 000000003465613001 , 000000003489313001 , 000000003633013001 , 000000003633113001 , 000000003643713001 ; 28) Model 22214C , CRANIAL NAVIGATION SW 2.1 , Serial Numbers: 000000000034814001 , 000000000034914001 , 000000000059214001 , 000000000266114001 , 000000001118214001 , 000000001320614001 , 000000001496814001 , 000000001855614001 , 000000001933214001 , 000000001949014001 , 000000001950314001 , 000000002549514001 , 000000003648014001 , 000000003671614001 , 000000003816414001 , 000000003818813001 , 000000003818913001 , 000000003819013001 , 000000003848013001 , 000000003877714001 , 000000003896213001 , 000000003953413001 , 000000003954013001 , 000000003978813001 , 000000003978913001 , 000000003979013001 , 000000003979113001 , 000000003979213001 , 000000004058613001 , 000000004058713001 , 000000004062414001 , 000000004069313001 , 000000004069413001 , 000000004089813001 , 000000004153413001 , 000000004161613001 , 000000004334713001 , 000000004406013001 , 000000004439913001 , 000000004468913001 , 000000004469013001 , 000000004469113001 , 000000004486313001 , 000000004486413001 , 000000004486513001 , 000000004486613001 , 000000004486713001 , 000000004504313001 , 000000004538314001 , 000000004545113001 , 000000004612413001 , 000000004663813001 , 000000004663913001 , 000000004709113001 , 000000004783814001 , 000000004859613001 , 000000004859713001 , 000000004887513001 , 000000004988313001 , 000000005006513001 , 000000005066313001 , 000000005153913001 , 000000005173713001 , 000000005173813001 , 000000005173913001 , 000000005274015001 , 000000005275513001 , 000000005429413001 , 000000005447613001 , 000000005504713001 , 000000005555513001 , 000000005571213001 , 000000005614113001 , 000000005614213001 , 000000005632713001 , 000000005655613001 , 000000005734813001 , 000000005749813001 , 000000005783213001 , 000000005783313001 , 000000005809913001 , 000000005843413001 , 000000005858813001 , 000000005933613001 , 000000005933713001 , 000000006082113001 , 000000006082213001 , 000000006089613001 , 000000006110313001 , 000000006133613001 , 000000006260615001 , 000000006264013001 , 000000006388913001 , 000000006389013001 , 000000006389113001 , 000000006389213001 , 000000006389313001 , 000000006389413001 , 000000006389513001 , 000000006421115001 , 000000006501613001 , 000000006642913001 , 000000006678013001 , 000000006727313001 , 000000006787613001 , 000000006876713001 , 000000006914715001 , 000000006963413001 , 000000006963513001 , 000000006965115001 , 000000006986013001 , 000000006986113001 , 000000007070313001 , 000000007070413001 , 000000007104213001 , 000000007122413001 , 000000007133613001 , 000000007133713001 , 000000007152313001 , 000000007183813001 , 000000007222213001 , 000000007275913001 , 000000007276013001 , 000000007298113001 , 000000007335813001 , 000000007386913001 , 000000007505713001 , 000000007582914001 , 000000007597214001 , 000000007615214001 , 000000007679014001 , 000000007695914001 , 000000007739514001 , 000000007748814001 , 000000007778815001 , 000000007778915001 , 000000007779015001 , 000000007779115001 , 000000007779215001 , 000000007845614001 , 000000007855114001 , 000000007864215001 , 000000007864315001 , 000000007864415001 , 000000007864515001 , 000000007864615001 , 000000007864715001 , 000000007887514001 , 000000007887614001 , 000000007931114001 , 000000007952814001 , 000000008108414001 , 000000008146114001 , 000000008169214001 , 000000008214914001 , 000000008252814001 , 000000008252914001 , 000000008253014001 , 000000008253114001 , 000000008270014001 , 000000008288414001 , 000000008288514001 , 000000008345715001 , 000000008352914001 , 000000008387414001 , 000000008412014001 , 000000008442114001 , 000000008442214001 , 000000008451814001 , 000000008465514001 , 000000008528214001 , 000000008569214001 , 000000008576714001 , 000000008679414001 , 000000008795114001 , 000000008921914001 , 000000008930314001 , 000000008952114001 , 000000008968714001 , 000000008968814001 , 000000008968914001 , 000000008984714001 , 000000009086514001 , 000000009148214001 , 000000009192514001 , 000000009212114001 , 000000009379914001 , 000000009440114001 , 000000009468614001 , 000000009506614001 , 000000009533714001 , 000000009659414001 , 000000009688014001 , 000000009780614001 , 000000009780714001 , 000000009990514001 , 000000009990614001 ; 29) Model 71000 , VV SOFTWARE UPGRADE CRANIAL 3.X TO 6.01 , Serial Numbers: 71000/21628 , 71000-103744-001 , 71000-103745-002 , 05-49480-71005 ; 30) Model 71006 , UPG VV CRANIAL 6.01 TO CRANIAL 7.0.X , Serial Numbers: 000000002899209001 , 000000003143809001 , 000000004297109001 , 6032908001 , 05-50560-71006 , 05-52155-71006 , 08-148612-71006 ; 31) Model 71008 , UPG VV CRANIAL 7.0 TO CRANIAL 7.5 , Serial Number: 000000004384709001 ; 32) Model 71011 , UPG CRA ESSENTIAL 1.0 TO UNLIMIMITED 1.0 , Serial Numbers: 000000004150309001 , 000000004441110001 ; 33) Model 71011A , UPGRADE CRANIAL ESS 1.0.1 TO UNL 1.0.1 , Serial Numbers: 000000007678511001 , 000000008548411001 ; 34) Model 71012 , UPGRADE VV CRANIAL 7.9 TO UNLIMITED 1.0 , Serial Number: 000000004337709001 ; 35) Model 71012A , UPGRADE VV CRANIAL 7.9.1 TO UNL 1.0.1 , Serial Numbers: 000000005629513001 , 000000005629613001 , 000000005629713001 , 000000005629913001 , 000000005676213001 , 000000005676313001 , 000000005769113001 , 000000005809113001 ; 36) Model 71013 , UPG KOLIBRI CRANIAL 2.7 TO ESSENTIAL 1.0 , Serial Number: 000000002811109001 ; 37) Model 71017 , UPG TO CRAN 2.x FROM CRAN UNLIMITED 1.0 , Serial Numbers: 000000000005412001 , 000000000060612001 , 000000000108312001 , 000000000108412001 , 000000000108512001 , 000000000251912001 , 000000000316012001 , 000000000388112001 , 000000000721512001 , 000000000722012001 , 000000001002812001 , 000000001015412001 , 000000001114112001 , 000000001114212001 , 000000001279512001 , 000000001291612001 , 000000001311912001 , 000000001336712001 , 000000001358812001 , 000000001511812001 , 000000001652012001 , 000000001757512001 , 000000002034512001 , 000000002777513001 , 000000002788013001 , 000000002911513001 , 000000002958813001 , 000000003056913001 , 000000003067913001 , 000000003094513001 , 000000003151913001 , 000000003187813001 , 000000003242113001 , 000000003538413001 , 000000007545311001 , 000000007587511001 , 000000007678011001 , 000000007725111001 , 000000007888511001 , 000000008050311001 , 000000008084411001 , 000000008231511001 , 000000008264411001 , 000000008283511001 , 000000008377711001 , 000000008444611001 , 000000008529511001 , 000000008579211001 , 000000008579311001 , 000000008579411001 , 000000008676811001 , 000000008676911002 , 000000008855711001 , 000000009001312001 , 000000009002812001 , 000000009079812001 , 000000009146112001 , 000000009162712001 , 000000009168712001 , 000000009187212001 , 000000009208512001 , 000000009411312001 , 000000009470312001 , 000000009470412001 , 000000009484312001 , 000000009599812001 , 000000009632012001 , 000000009652512001 , 000000009760312001 , 000000009840212001 , 000000009931412001 , 000000009931512001 ; 38) Model 71017A , UPG TO CRAN 2.x FROM CRAN UNLIMITED 1.0 , Serial Numbers: 000000001088214001 , 000000002036614001 , 000000002632314001 , 000000002855614001 , 000000003113714001 , 000000003113814001 , 000000003531414001 , 000000003603714001 , 000000003753014001 , 000000003753114001 , 000000003924713001 , 000000003979114001 , 000000004041513001 , 000000004111013001 , 000000004152813001 , 000000004152913001 , 000000004321813001 , 000000004321913001 , 000000004322013001 , 000000004519013001 , 000000004591513001 , 000000004813913001 , 000000004866313001 , 000000004866413001 , 000000005172113001 , 000000005650913001 , 000000006367713001 , 000000006367813001 , 000000006662513001 , 000000006752013001 , 000000006894213001 , 000000006894313001 , 000000006909613001 , 000000007311115001 , 000000007365613001 , 000000007432713001 , 000000007514713001 , 000000007624313001 , 000000007657214001 , 000000007704815001 , 000000007765214001 , 000000008248514001 , 000000008508414001 , 000000009319814001 , 000000009378914001 , 000000009466914001 ; 39) Model 71051 , UPD VV CRANIAL 7.5.X TO 7.6.X , Serial Number: 000000002382609001 ; 40) Model 71053 , UPD VV CRANIAL 7.6.X TO CRANIAL7.7.X , Serial Number: 06-88103-71053 ; 41) Model 71056 , UPD VV CRANIAL 7.7.X TO CRANIAL7.8.X , Serial Numbers: 000000001425108001 , 000000001462008001 , 000000003671509001 , 000000009258012001 ; 42) Model 71063 , UPG KOL CRANIAL 2.5.X TO CRANIAL 2.6.X , Serial Number: 07-111143-71063 ; 43) Model 71067 , UPDATE VV NAV SW CRANIAL 7.8 TO 7.9 , Serial Numbers: 000000003270709001 , 000000003428909001 , 000000004577510001 ; 44) Model 71067A , UPDATE VV NAV SW CRANIAL 7.8 TO 7.9.1 , Serial Numbers: 000000000253112001 , 000000000452712001 , 000000001446312001 , 000000001533312001 , 000000001708612001 , 000000002492312001 , 000000004691813001 , 000000009147012001 , 000000009537312001 , 000000009641812001 , 000000009653312001 ; 45) Model 71069 , UPD KOLIBRI NAV SW CRANIAL 2.6 TO 2.7 , Serial Numbers: 000000003189109001 , 000000003189209001 , 000000003200109001 , 000000003288809001 , 000000003498009001 , 000000004323109001 , 000000004576710001 , 000000006333310001 , 000000006333410001 ; 46) Model 71075 , UPG CRA ESS 1.0 FROM ANY PREV. KOL SW , Serial Number: 000000005026310001 ; 47) Model 71076 , UPG VV CRA 7.0 FROM ANY PREV. VV CRA SW , Serial Number: 000000007742711001 ; 48) Model 71077 , UPG CRA UNL 1.0 FROM VV CRA 7.X , Serial Numbers: 000000005437910001 , 000000005587010001 , 000000006351510001 ; 49) Model 71077A , UPGRADE CRANIAL UNL 1.0.1 FROM VV 7.X , Serial Numbers: 000000002989913001 , 000000002990013001 , 000000007676711001 , 000000008849411001 , 000000009150612001 ; 50) Model 71086 , UPG TO CRANIAL NAV SW 2.X FROM ANY PREV , Serial Numbers: 000000000110212001 , 000000000268812001 , 000000000268912001 , 000000000269112001 , 000000000306812001 , 000000000317512001 , 000000000420912001 , 000000000564112001 , 000000000627612001 , 000000000776012001 , 000000000837012001 , 000000001030812001 , 000000001157712001 , 000000001489112001 , 000000001510112001 , 000000001694212001 , 000000002957213001 , 000000004002213001 , 000000007487311001 , 000000007494511001 , 000000007561011001 , 000000007584811001 , 000000007754211001 , 000000007766011001 , 000000007832511001 , 000000007896911001 , 000000008147311001 , 000000008292611001 , 000000008312911001 , 000000008537511001 , 000000008610611001 , 000000008623211001 , 000000008626411001 , 000000008655511001 , 000000008796311001 , 000000008891611001 , 000000009025612001 , 000000009232112001 , 000000009301712001 , 000000009388712001 , 000000009537112001 , 000000009737712001 , 000000009737712002 , 000000009737712003 , 000000009856112001 , 000000009900812001 , 000000009904912001 , 000000009988512001 , 000000009991312001 , 000000009991412001 ; 51) Model 71086A , UPG TO CRANIAL NAV SW 2.X FROM ANY PREV , Serial Numbers: 000000002036914001 , 000000002344114001 , 000000004470113001 , 000000004507013001 , 000000004507113001 , 000000004918215001 , 000000005094113001 , 000000005658713001 , 000000006162913001 , 000000007326413001 , 000000007513413001 , 000000007870114001 , 000000008813214001 , 000000009479914001 ; 52) Model 71088 , UPGR TO CRANIAL NAV SW 2.X 11-02-18JUG2 , Serial Numbers: 000000007578911001 , 000000007626611001 ; 53) Model 71093 , GEN UPG CRANIAL NAV SW FOR CURVE , Serial Numbers: 000000000350812001 , 000000000619012001 , 000000000645412001 , 000000000676712001 , 000000000957112001 , 000000001091112001 , 000000001726912001 , 000000001727012001 , 000000002541512001 , 000000002583812001 , 000000002765713001 , 000000003236413001 , 000000003237213001 , 000000009412112001 , 000000009626512001 , 000000009669712001 , 000000009700112001 ; 54) Model 71093A , GEN UPG CRANIAL NAV SW FOR CURVE/KICK , Serial Numbers: 000000000494614001 , 000000001210114001 , 000000001239214001 , 000000002580914001 , 000000003754914001 , 000000003828313001 , 000000004239713001 , 000000004315913001 , 000000004591713001 , 000000004606413001 , 000000004785513001 , 000000004881313001 , 000000005430113001 , 000000005602113001 , 000000005602213001 , 000000005658813001 , 000000005658913001 , 000000005669013001 , 000000005982813001 , 00000 0006044113001 , 000000006044213001 , 000000006395013001 , 000000006395113001 , 000000006501913001 , 000000006643113001 , 000000006738213001 , 000000006878013001 , 000000007095113001 , 000000007095213001 , 000000007223613001 , 000000007248815001 , 000000007377813001 , 000000007487813001 , 000000007641214001 , 000000007641314001 , 000000007819514001 , 000000007844914001 , 000000007931414001 , 000000008021914001 , 000000008260014001 , 000000008296214001 , 000000008319314001 , 000000008454614001 , 000000008500114001 , 000000008795614001 , 000000008860614001 , 000000008860714001 , 000000008878214001 , 000000009480014001 ; 55) Model 71096 , UPG TO CRAN 2.x CURVE FROM CRAN UNL 1.0 , Serial Numbers: 000000000239112001 , 000000000239212001 , 000000000239312001 , 000000000330112001 , 000000000789212001 , 000000000789312001 , 000000000998012001 , 000000001081912001 , 000000001186712001 , 000000001231712001 , 000000001352512001 , 000000001620512001 , 000000001706812001 , 000000001749112001 , 000000001895012001 , 000000002056312001 , 000000002098912001 , 000000002235012001 , 000000002235112001 , 000000002360412001 , 000000002696813001 , 000000002777313001 , 000000002777413001 , 000000002878213001 , 000000003057013001 , 000000003261813001 , 000000003314513001 , 000000003450613001 , 000000003450713001 , 000000003450813001 , 000000003602013001 , 000000003609213001 , 000000003609313001 , 000000003609413001 , 000000003666113001 , 000000009232212001 , 000000009389912001 , 000000009530112001 , 000000009764012001 ; 54) Model 71096A , UPG TO CRAN 2.x CURVE FROM CRAN UNL 1.0 , Serial Numbers: 000000001634614001 , 000000002290314001 , 000000003924813001 , 000000003960613001 , 000000003960713001 , 000000004303913001 , 000000004533313001 , 000000005397113001 , 000000005503813001 , 000000005535413001 , 000000006656213001 , 000000006894413001 , 000000006894513001 , 000000006941613001 , 000000007196713001 , 000000007365713001 , 000000007595914001 , 000000007927114001 , 000000008479114001 , 000000008543914001 , 000000009189414001 , 000000009189514001 , 000000009485314001 , 000000009564714001 , 000000009564814001 , 000000009908214001 , 000000009987114001 ; 55) Model 71097 , UPG TO CRAN 2.X CURVE FROM CRAN 2.X STD , Serial Numbers: 000000001620412001 , 000000001662512001 , 000000003087513001 , 000000003756313001 , 000000008548011001 ; 56) Model 71097A , UPG TO CRAN 2.X CURVE FROM CRAN 2.X STD , Serial Numbers: 000000001887414001 , 000000002536114001 , 000000004403613001 , 000000005779713001 , 000000006658513001 , 000000007168513001 , 000000007181513001 , 000000007418613001 , 000000007707214001 , 000000008465014001
Where was it sold?
Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Brainlab AG
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|---|---|---|---|---|---|
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| Device | CLASS II | ExacTrac Dynamic recalled by Brainlab AG | Brainlab AG | Device Malfunction | Nationwide |
| Device | CLASS II | ExacTrac Dynamic recalled by Brainlab AG | Brainlab AG | Device Malfunction | 20 states |
| Device | CLASS II | ExacTrac Dynamic recalled by Brainlab AG | Brainlab AG | Processing Deviation | Nationwide |
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| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
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