CLASS II Device recall · Reported 3 Feb 2016 · FDA Enforcement Report

Vantage Panoramic X-Ray System used to perform dental recalled

Midmark is recalling Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological, distributed in 34 states. The recall was initiated on 4 Sep 2014 and the FDA has classified it as Class II.

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Lot, batch or date codesModel Number: 60-A0001; ZA05002 , ZA05003 , ZA05004 , ZA05005 , ZA05006 , ZA05007 , ZA05008 , ZA05009 , ZA05010 , ZA05011 , ZA05012 , ZA05013 , ZA05014 , ZA05015 , ZA05016 , ZA05017 , ZA05018 , ZA05019 , ZA05020 , ZA05021 , ZA05022 , ZA05023 , ZB51001 , ZB51002 , ZB51003 , ZB51004 , ZB51007 , ZB51008 , ZB51009 , ZB51010 , ZB51011 , ZB51012 , ZB51013 , ZB51014 , ZB51015 , ZB51016 , ZB51017 , ZB51018 , ZB51019 , ZB51021 , ZB51023 , ZB51024 , ZB51025 , ZB51026 , ZB51027 , ZB51028 , ZB51029 , ZB51030 , ZB51031 , ZB51032 , ZB51034 , ZB51035 , ZB51036 , ZB52001 , ZB52002 , ZB52003 , ZB52004 , ZB52005 , ZB52006 , ZB52007 , ZB52008 , ZB52009 , ZB52010 , ZB52011 , ZB52012 , ZB52013 , ZB52014 , ZB52015 , ZB52016 , ZB52017 , ZB52018 , ZB52019 , ZB52020 , ZB52021 , ZB52022 , ZB52023 , ZB92002 , ZB92003 , ZB92004 , ZB92005 , ZB92006 , ZB92007 , ZB92008 , ZB92009 , ZB92011 , ZC38001 , ZC38002 , ZC38003 , ZC38004 , ZC38005 , ZC38007 , ZC38008 , ZC38009 , ZC38010 , ZC38011 , ZC38013 , ZC38015 , ZC38016 , ZC38017 , ZC38018 , ZC38019 , ZC38020 , ZC38021 , ZC38022 , ZC39001 , ZC39002 , ZE09001 , ZE09002 , ZE09003 , ZE09004 , ZE09006 , ZE09007 , ZE09008 , ZE09009 , ZE09010 , ZE09011 , ZE09012 , ZE09014 , ZE09015 , ZE09016 , ZE09017 , ZE09018 , ZE09019 , ZE09020 , ZE47001 , ZE47002 , ZE47003 , ZE47004 , ZE47005 , ZE47006 , ZE47007 , ZE47008 , ZE47009 , ZE47010 , ZE47011 , ZE47012 , ZE47013 , ZE47014 , ZE47015 , ZE47016 , ZE47017 , ZE47018 , ZE47019 , ZE47020 , ZE47021 , ZE77001 , ZE77002 , ZE77003 , ZE77004 , ZE77005 , ZE77006 , ZE77007 , ZE77008 , ZE77009 , ZE77010 , ZF41001 , ZF41002 , ZF41003 , ZF41004 , ZF41005 , ZF41006 , ZF41007 , ZF41008 , ZF41009 , ZF41010 , ZF41011 , ZF41012 , ZF41013 , ZF41014 , ZF41015 , ZF41016 , ZF41017 , ZF41018 , ZF41019 , ZF41020 , ZF41021 , ZF41022 , ZF41023 , ZF41024 , ZF95001 , ZF95002 , ZF95003 , ZF95004 , ZF95005 , ZF95006 , ZF95007 , ZF95008 , ZF95009 , ZF95010 , ZF95011 , ZF95012 , ZF95013 , ZF95014 , ZF95015 , ZF95016 , ZF95017 , ZG61001 , ZG61002 , ZG61003 , ZG61004 , ZG61005 , ZG61006 , ZG61007 , ZG61008 , ZG61009 , ZG61010 , ZG61011 , ZG61012 , ZG61013 , ZG61014 , ZG61015 , ZG61016 , ZG61017 , ZG61018 , ZG61019 , ZG61020 , ZG61021 , ZG61022 , ZG61023 , ZG61025 , ZG61026 , ZG61027 , ZG61028 , ZG61029 , ZG93001 , ZG93002 , ZG93003 , ZG93004 , ZG93005 , ZG93006 , ZG93008 , ZG93009 , ZG93010 , ZG93011 , ZG93012 , ZG93013 , ZG93014 , ZG93015 , ZG93016 , ZG93017 , ZG93018 , ZG93019 , ZG93020 , ZG93021 , ZG93022 , ZG93023 , ZG93024 , ZH20001 , ZH20002 , ZH20003 , ZH20004 , ZH20005 , ZH20006 , ZH20007 , ZH20008 , ZH20009 , ZH20010 , ZH20011 , ZH20012 , ZH20013 , ZH20014 , ZH20016 , ZH20017 , ZH20019 , ZH20020 , ZH20021 , ZH20022 , ZH20023 , ZH20024 , ZH20025 , ZH20026 , ZH20027 , ZH20028 , ZH20029 , ZH36001 , ZH36002 , ZH36003 , ZH36004 , ZH36005 , ZH36006 , ZH36007 , ZH36008 , ZH36009 , ZH36011 , ZH36012 , ZH36013 , ZH36014 , ZH36015 , ZH36016 , ZH36018 , ZH37002 , ZH37003 , ZH37004 , ZH37005 , ZH37006 , ZH37007 , ZH37008 , ZH37009 , ZH37010 , ZH37012 , ZH37013 , ZH37014 , ZH37015 , ZJ26001 , ZJ26002 , ZJ26003 , ZJ26004 , ZJ26005 , ZJ26006 , ZJ26007 , ZJ26008 , ZJ26009 , ZJ26010 , ZJ26011 , ZJ26012 , ZJ26013 , ZJ26014 , ZJ26015 , ZJ26016 , ZJ26017 , ZJ26018 , ZJ26019 , ZJ26020 , ZJ26021 , ZJ26022 , ZJ26023 , ZJ26024 , ZJ26025 , ZJ26026 , ZJ26027 , ZJ26028 , ZK04002 , ZK04003 , ZK04004 , ZK04005 , ZK04006 , ZK51001 , ZK51002 , ZK51003 , ZK51004 , ZK51005 , ZK51006 , ZK51007 , ZK51008 , ZK51009 , ZK51010 , ZK51011 , ZK51012 , ZK51013 , ZK51015 , ZK51016 , ZK51017 , ZK58001 , ZK58002 , ZK58003 , ZK58004 , ZK58005 , ZK58006 , ZK58007 , ZK58008 , ZK58009 , ZK58010 , ZK58011 , ZK58012 , ZK58013 , ZK58014 , ZK58015 , ZK58016 , ZK58017 , ZK58018 , ZK58019 , ZK58020 , ZK58021 , ZK58022 , ZK58023 , ZK58024 , ZM18018 , ZM81001 , ZM81002 , ZM81003 , ZM81004 , ZM81005 , ZM81006 , ZM81007 , ZM81008 , ZM81009 , ZM81010 , ZM81011 , ZM81012 , ZM81013 , ZM81014 , ZM81015 , ZM81016 , ZM81017 , ZM81018 , ZM81019 , ZM81020 , ZM81021 , ZM81022 , ZM81023 , ZM81025 , ZM81026 , ZM81027 , ZM81029 , ZM81030 , ZM81031 , ZN44001 , ZN44002 , ZN44003 , ZN44004 , ZN44005 , ZN44006 , ZN44007 , ZN44008 , ZN44009 , ZN44010 , ZN44011 , ZN44012 , ZN44013 , ZN44014 , ZN44015 , ZN44016 , ZN44017 , ZN44018 , ZN44019 , ZN44020 , ZN44021 , ZN44022 , ZN44023 , ZN44024 , ZP01002 , ZP01003 , ZP01004 , ZP01005 , ZP01006 , ZP01007 , ZP01008 , ZP01011 , ZP01012 , ZP01013 , ZP01014 , ZP01015 , ZP01016 , ZP01017 , ZP01018 , ZP01019 , ZP01020 , ZP01021 , ZP01022 , ZP01023 , ZP01024 , ZP01025 , ZP01026 , ZP01027 , ZP01028 , ZP01029 , ZP01030 , ZP01031 , ZP01032 , ZP01033 , ZP01034 , ZP01035 , ZP01036 , ZP01037 , ZP01039 , ZP01041 , ZP01042 , ZP01043 , ZP0I034 , ZP42001 , ZP42002 , ZP42003 , ZP42004 , ZP42005 , ZP42006 , ZP42007 , ZP42008 , ZP42009 , ZP42010 , ZP42011 , ZP42012 , ZP42014 , ZP42015 , ZP42016 , ZP42017 , ZP42018 , ZP42019 , ZP42020 , ZP42021 , ZP42022 , ZR45001 , ZR45002 , ZR45003 , ZR45004 , ZR45005 , ZR45006 , ZR45007 , ZR45008 , ZR45009 , ZR45010 , ZR45011 , ZR45012 , ZR45013 , ZR45014 , ZR45015 , ZR45016 , ZR45017 , ZR45018 , ZR45019 , ZR45020 , ZR45021 , ZR45022 , ZR45023 , ZR45024 , ZR45025 , ZR45026 , ZR48001 , ZR48002 , ZR48003 , ZR48004 , ZR48005 , ZR48006 , ZR48007 , ZR48008 , ZR48009 , ZR48010 , ZR48011 , ZR48012 , ZR48013 , ZR48014 , ZR48015 , ZR48016 , ZR48017 , ZR48018 , ZR48019 , ZR48020 , ZR48021 , ZR48022 , ZS43001 , ZS43002 , ZS43003 , ZS43004 , ZS43005 , ZS43006 , ZS43007 , ZS43008 , ZS43009 , ZS43010 , ZS43011 , ZS43012 , ZS43013 , ZS43014 , ZS43015 , ZS43016 , ZS43017 , ZS43018 , ZS43019 , ZS54002 , ZS54004 , ZS54005 , ZS54006 , ZS54007 , ZS54008 , ZS54009 , ZS54010 , ZS54011 , ZS54012 , ZS54013 , ZS54014 , ZS54015 , ZS54016 , ZS54017 , ZS54019 , ZS54020 , ZS54021 , ZS59001 , ZS59002 , ZS59003 , ZS59004 , ZS59005 , ZS59006 , ZS59007 , ZS59008 , ZS59009 , ZS59010 , ZS59011 , ZS59012 , ZS59013 , ZS59014 , ZS59015 , ZS59016 , ZS59017 , ZS59018 , ZS59019 , ZT18001 , ZT18002 , ZT18003 , ZT18004 , ZT18005 , ZT18006 , ZT18007 , ZT18008 , ZT18009 , ZT18010 , ZT18011 , ZT18012 , ZT18013 , ZT18014 , ZT18015 , ZT18016 , ZT18017 , ZT18018 , ZT18019 , ZT18020 , ZT18021 , ZT18022 , ZT18023 , ZT18024 , ZT18025 , ZT18026 , ZT18027 , ZT18028 , ZT18029 , ZT18030 , ZT18031 , ZT18032 , ZT18033 , ZT18034 , ZT18035 , ZT18036 , ZT18037 , ZT18038 , ZT18039 , ZT18040 , ZT27001 , ZT27002 , ZT27003 , ZT27004 , ZT27005 , ZT27006 , ZT27007 , ZT27008 , ZT27009 , ZT27010 , ZT27011 , ZT27012 , ZT27013 , ZT27014 , ZT27015 , ZT27016 , ZT27017 , ZT27018 , ZT27019 , ZT27020 , ZT27021 , ZT27022 , ZT27023 , ZT27024 , ZU33001 , ZU33002 , ZU33003 , ZU33004 , ZU33005 , ZU33007 , ZU33008 , ZU33009 , ZU33011 , ZU33012 , ZU33013 , ZU33014 , ZU33015 , ZU33016 , ZU33017 , ZU33018 , ZU33019 , ZU33020 , ZU33021 , ZU33022 , ZU33023 , ZU33024 , ZU33025 , ZU33026 , ZU33027 , ZU33029 , ZU33030 , ZU33031 , ZU33032 , ZU33033 , ZU33034 , ZU33035 , ZV29001 , ZV29002 , ZV29003 , ZV29004 , ZV29005 , ZV29006 , ZV29007 , ZV29008 , ZV29009 , ZV29010 , ZV78001 , ZV78002 , ZV78003 , ZV78004 , ZV78006 , ZV78007 , ZV78008 , ZV78009 , ZV78010 , ZV78011 , ZV78012 , ZV78013 , ZV78014 , ZV78015 , ZV78016 , ZV78017 , ZV78018 , ZV78019 , ZV78020 , ZV78021 , ZV78022 , ZW15001 , ZW15002 , ZW15003 , ZW15004 , ZW15005 , ZW15006 , ZW15007 , ZW15008 , ZW15009 , ZW15011 , ZW15012 , ZW15013 , ZW15014 , ZW15015 , ZW15016 , ZW15017 , ZW15018 , ZW15019 , ZW15020 , ZW15021 , ZW15022 , ZW34002 , ZW34003 , ZW34004 , ZW34006 , ZW34007 , ZW34008 , ZW34009 , ZW34010 , ZW34011 , ZW34013 , ZW34015 , ZW34016 , ZW34017 , ZW34018 , ZW34019 , ZW34020 , ZW34021 , ZW34022 , ZW74007 , ZW74008 , ZW74009 , ZW74010 , ZW74011 , ZY49001 , ZY49002 , ZY49003 , ZY49004 , ZY49005 , ZY49006 , ZY49007 , ZY49009 , ZY49011 , ZY49012 , ZY49014 , ZY49016 , ZY49017 , ZY49018 , ZY49019 , ZY49020 , ZY49021 , ZZ02001 , ZZ02002 , ZZ02003 , ZZ02004 , ZZ02005 , ZZ02006 , ZZ02007 , ZZ02008 , ZZ02009 , ZZ02011 , ZZ02012 , ZZ02013 , ZZ02014 , ZZ02015 , ZZ02016 , ZZ02017 , ZZ02018 , ZZ02019 , ZZ02020 , ZZ02021 , ZZ02022 , ZZ02023 , ZZ02024 , ZZ08001 , ZZ08002 , ZZ08003 , ZZ08004 , ZZ08005 , ZZ08006 , ZZ08007 , ZZ08008 , ZZ08009 , ZZ08010 , ZZ08011 , ZZ08012 , ZZ08013 , ZZ08014 , ZZ08015 , ZZ08016 , ZZ08018 , ZZ08019 , ZZ08020 , ZZ08021 , ZZ08022 , ZZ08023 , ZZ69000 , ZZ69003 , ZZ69004 , ZZ69005

Quantity recalled832 systems

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-0651-2016
FDA event ID: 70765
Recalling firm: Midmark, Lincolnshire, IL
Classification: Class II
Status: Terminated
Recall initiated: 4 Sep 2014
FDA classified: 25 Jan 2016
Reported: 3 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

4 Sep 2014	Recall initiated by company
25 Jan 2016	Classified by FDA	+508 days
3 Feb 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometric radiographic examinations for use in orthodontic treatment planning and evalu

Where it was distributed

Worldwide Distribution - US including AL, AR, AZ, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI; and Internationally to Australia, Belgium, Canada, Czech Republic, France, Hungary, Lithuania, New Zealand, Poland, Russia, Saudi Arabia, South Africa, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Alabama Arkansas Arizona Colorado Connecticut Delaware Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Michigan Minnesota Missouri Mississippi Nebraska

Questions about this recall

Why was it recalled?

Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.

Which lots are affected?

Model Number: 60-A0001; ZA05002 , ZA05003 , ZA05004 , ZA05005 , ZA05006 , ZA05007 , ZA05008 , ZA05009 , ZA05010 , ZA05011 , ZA05012 , ZA05013 , ZA05014 , ZA05015 , ZA05016 , ZA05017 , ZA05018 , ZA05019 , ZA05020 , ZA05021 , ZA05022 , ZA05023 , ZB51001 , ZB51002 , ZB51003 , ZB51004 , ZB51007 , ZB51008 , ZB51009 , ZB51010 , ZB51011 , ZB51012 , ZB51013 , ZB51014 , ZB51015 , ZB51016 , ZB51017 , ZB51018 , ZB51019 , ZB51021 , ZB51023 , ZB51024 , ZB51025 , ZB51026 , ZB51027 , ZB51028 , ZB51029 , ZB51030 , ZB51031 , ZB51032 , ZB51034 , ZB51035 , ZB51036 , ZB52001 , ZB52002 , ZB52003 , ZB52004 , ZB52005 , ZB52006 , ZB52007 , ZB52008 , ZB52009 , ZB52010 , ZB52011 , ZB52012 , ZB52013 , ZB52014 , ZB52015 , ZB52016 , ZB52017 , ZB52018 , ZB52019 , ZB52020 , ZB52021 , ZB52022 , ZB52023 , ZB92002 , ZB92003 , ZB92004 , ZB92005 , ZB92006 , ZB92007 , ZB92008 , ZB92009 , ZB92011 , ZC38001 , ZC38002 , ZC38003 , ZC38004 , ZC38005 , ZC38007 , ZC38008 , ZC38009 , ZC38010 , ZC38011 , ZC38013 , ZC38015 , ZC38016 , ZC38017 , ZC38018 , ZC38019 , ZC38020 , ZC38021 , ZC38022 , ZC39001 , ZC39002 , ZE09001 , ZE09002 , ZE09003 , ZE09004 , ZE09006 , ZE09007 , ZE09008 , ZE09009 , ZE09010 , ZE09011 , ZE09012 , ZE09014 , ZE09015 , ZE09016 , ZE09017 , ZE09018 , ZE09019 , ZE09020 , ZE47001 , ZE47002 , ZE47003 , ZE47004 , ZE47005 , ZE47006 , ZE47007 , ZE47008 , ZE47009 , ZE47010 , ZE47011 , ZE47012 , ZE47013 , ZE47014 , ZE47015 , ZE47016 , ZE47017 , ZE47018 , ZE47019 , ZE47020 , ZE47021 , ZE77001 , ZE77002 , ZE77003 , ZE77004 , ZE77005 , ZE77006 , ZE77007 , ZE77008 , ZE77009 , ZE77010 , ZF41001 , ZF41002 , ZF41003 , ZF41004 , ZF41005 , ZF41006 , ZF41007 , ZF41008 , ZF41009 , ZF41010 , ZF41011 , ZF41012 , ZF41013 , ZF41014 , ZF41015 , ZF41016 , ZF41017 , ZF41018 , ZF41019 , ZF41020 , ZF41021 , ZF41022 , ZF41023 , ZF41024 , ZF95001 , ZF95002 , ZF95003 , ZF95004 , ZF95005 , ZF95006 , ZF95007 , ZF95008 , ZF95009 , ZF95010 , ZF95011 , ZF95012 , ZF95013 , ZF95014 , ZF95015 , ZF95016 , ZF95017 , ZG61001 , 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ZM81021 , ZM81022 , ZM81023 , ZM81025 , ZM81026 , ZM81027 , ZM81029 , ZM81030 , ZM81031 , ZN44001 , ZN44002 , ZN44003 , ZN44004 , ZN44005 , ZN44006 , ZN44007 , ZN44008 , ZN44009 , ZN44010 , ZN44011 , ZN44012 , ZN44013 , ZN44014 , ZN44015 , ZN44016 , ZN44017 , ZN44018 , ZN44019 , ZN44020 , ZN44021 , ZN44022 , ZN44023 , ZN44024 , ZP01002 , ZP01003 , ZP01004 , ZP01005 , ZP01006 , ZP01007 , ZP01008 , ZP01011 , ZP01012 , ZP01013 , ZP01014 , ZP01015 , ZP01016 , ZP01017 , ZP01018 , ZP01019 , ZP01020 , ZP01021 , ZP01022 , ZP01023 , ZP01024 , ZP01025 , ZP01026 , ZP01027 , ZP01028 , ZP01029 , ZP01030 , ZP01031 , ZP01032 , ZP01033 , ZP01034 , ZP01035 , ZP01036 , ZP01037 , ZP01039 , ZP01041 , ZP01042 , ZP01043 , ZP0I034 , ZP42001 , ZP42002 , ZP42003 , ZP42004 , ZP42005 , ZP42006 , ZP42007 , ZP42008 , ZP42009 , ZP42010 , ZP42011 , ZP42012 , ZP42014 , ZP42015 , ZP42016 , ZP42017 , ZP42018 , ZP42019 , ZP42020 , ZP42021 , ZP42022 , ZR45001 , ZR45002 , ZR45003 , ZR45004 , ZR45005 , ZR45006 , ZR45007 , ZR45008 , ZR45009 , ZR45010 , ZR45011 , ZR45012 , ZR45013 , ZR45014 , ZR45015 , ZR45016 , ZR45017 , ZR45018 , ZR45019 , ZR45020 , ZR45021 , ZR45022 , ZR45023 , ZR45024 , ZR45025 , ZR45026 , ZR48001 , ZR48002 , ZR48003 , ZR48004 , ZR48005 , ZR48006 , ZR48007 , ZR48008 , ZR48009 , ZR48010 , ZR48011 , ZR48012 , ZR48013 , ZR48014 , ZR48015 , ZR48016 , ZR48017 , ZR48018 , ZR48019 , ZR48020 , ZR48021 , ZR48022 , ZS43001 , ZS43002 , ZS43003 , ZS43004 , ZS43005 , ZS43006 , ZS43007 , ZS43008 , ZS43009 , ZS43010 , ZS43011 , ZS43012 , ZS43013 , ZS43014 , ZS43015 , ZS43016 , ZS43017 , ZS43018 , ZS43019 , ZS54002 , ZS54004 , ZS54005 , ZS54006 , ZS54007 , ZS54008 , ZS54009 , ZS54010 , ZS54011 , ZS54012 , ZS54013 , ZS54014 , ZS54015 , ZS54016 , ZS54017 , ZS54019 , ZS54020 , ZS54021 , ZS59001 , ZS59002 , ZS59003 , ZS59004 , ZS59005 , ZS59006 , ZS59007 , ZS59008 , ZS59009 , ZS59010 , ZS59011 , ZS59012 , ZS59013 , ZS59014 , ZS59015 , ZS59016 , ZS59017 , ZS59018 , ZS59019 , ZT18001 , ZT18002 , ZT18003 , ZT18004 , ZT18005 , ZT18006 , ZT18007 , ZT18008 , ZT18009 , ZT18010 , ZT18011 , ZT18012 , ZT18013 , ZT18014 , ZT18015 , ZT18016 , ZT18017 , ZT18018 , ZT18019 , ZT18020 , ZT18021 , ZT18022 , ZT18023 , ZT18024 , ZT18025 , ZT18026 , ZT18027 , ZT18028 , ZT18029 , ZT18030 , ZT18031 , ZT18032 , ZT18033 , ZT18034 , ZT18035 , ZT18036 , ZT18037 , ZT18038 , ZT18039 , ZT18040 , ZT27001 , ZT27002 , ZT27003 , ZT27004 , ZT27005 , ZT27006 , ZT27007 , ZT27008 , ZT27009 , ZT27010 , ZT27011 , ZT27012 , ZT27013 , ZT27014 , ZT27015 , ZT27016 , ZT27017 , ZT27018 , ZT27019 , ZT27020 , ZT27021 , ZT27022 , ZT27023 , ZT27024 , ZU33001 , ZU33002 , ZU33003 , ZU33004 , ZU33005 , ZU33007 , ZU33008 , ZU33009 , ZU33011 , ZU33012 , ZU33013 , ZU33014 , ZU33015 , ZU33016 , ZU33017 , ZU33018 , ZU33019 , ZU33020 , ZU33021 , ZU33022 , ZU33023 , ZU33024 , ZU33025 , ZU33026 , ZU33027 , ZU33029 , ZU33030 , ZU33031 , ZU33032 , ZU33033 , ZU33034 , ZU33035 , ZV29001 , ZV29002 , ZV29003 , ZV29004 , ZV29005 , ZV29006 , ZV29007 , ZV29008 , ZV29009 , ZV29010 , ZV78001 , ZV78002 , ZV78003 , ZV78004 , ZV78006 , ZV78007 , ZV78008 , ZV78009 , ZV78010 , ZV78011 , ZV78012 , ZV78013 , ZV78014 , ZV78015 , ZV78016 , ZV78017 , ZV78018 , ZV78019 , ZV78020 , ZV78021 , ZV78022 , ZW15001 , ZW15002 , ZW15003 , ZW15004 , ZW15005 , ZW15006 , ZW15007 , ZW15008 , ZW15009 , ZW15011 , ZW15012 , ZW15013 , ZW15014 , ZW15015 , ZW15016 , ZW15017 , ZW15018 , ZW15019 , ZW15020 , ZW15021 , ZW15022 , ZW34002 , ZW34003 , ZW34004 , ZW34006 , ZW34007 , ZW34008 , ZW34009 , ZW34010 , ZW34011 , ZW34013 , ZW34015 , ZW34016 , ZW34017 , ZW34018 , ZW34019 , ZW34020 , ZW34021 , ZW34022 , ZW74007 , ZW74008 , ZW74009 , ZW74010 , ZW74011 , ZY49001 , ZY49002 , ZY49003 , ZY49004 , ZY49005 , ZY49006 , ZY49007 , ZY49009 , ZY49011 , ZY49012 , ZY49014 , ZY49016 , ZY49017 , ZY49018 , ZY49019 , ZY49020 , ZY49021 , ZZ02001 , ZZ02002 , ZZ02003 , ZZ02004 , ZZ02005 , ZZ02006 , ZZ02007 , ZZ02008 , ZZ02009 , ZZ02011 , ZZ02012 , ZZ02013 , ZZ02014 , ZZ02015 , ZZ02016 , ZZ02017 , ZZ02018 , ZZ02019 , ZZ02020 , ZZ02021 , ZZ02022 , ZZ02023 , ZZ02024 , ZZ08001 , ZZ08002 , ZZ08003 , ZZ08004 , ZZ08005 , ZZ08006 , ZZ08007 , ZZ08008 , ZZ08009 , ZZ08010 , ZZ08011 , ZZ08012 , ZZ08013 , ZZ08014 , ZZ08015 , ZZ08016 , ZZ08018 , ZZ08019 , ZZ08020 , ZZ08021 , ZZ08022 , ZZ08023 , ZZ69000 , ZZ69003 , ZZ69004 , ZZ69005

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 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 Midmark

All 8

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide

Other Imaging Equipment recalls

All 2,349

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Xact mole marker for mammography recalled by Solstice	Solstice	Other	Nationwide
28 Oct 2026Device	CLASS I	Philips Lumify Diagnostic Ultrasound System recalled	Philips Ultrasound	Other	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide