CLASS II Device recall · Reported 11 Nov 2015 · FDA Enforcement Report
iOS Galileo Application recalled by Otto Bock Healthcare
Otto Bock Healthcare is recalling iOS Galileo Application, distributed nationwide in the US. The recall was initiated on 23 Oct 2015 and the FDA has classified it as Class II.
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-0209-2016
- FDA event ID
- 72488
- Recalling firm
- Otto Bock Healthcare, Duderstadt, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Oct 2015
- FDA classified
- 5 Nov 2015
- Reported
- 11 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 23 Oct 2015 | Recall initiated by company | |
| 5 Nov 2015 | Classified by FDA | +13 days |
| 11 Nov 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. When sitting, the prosthetic foot can go into the Relief Function to move the footplate towards the ground. When operating machines with foot pedals (e.g. a car) the foot could get stuck under the foot pedal and block it or, with the foot on the pedal, it could cause unintended vehicle acceleration.
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
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
Where it was distributed
Worldwide Distribution - US (nationwide) and to the countries of : Austria, Belgium, Germany, Israel, Luxembourg and Sweden.
Questions about this recall
Is iOS Galileo Application recalled?
Yes. Otto Bock Healthcare recalled iOS Galileo Application on 23 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0209-2016.
Why was it recalled?
A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. When sitting, the prosthetic foot can go into the Relief Function to move the footplate towards the ground. When operating machines with foot pedals (e.g. a car) the foot could get stuck under the foot pedal and block it or, with the foot on the pedal, it could cause unintended vehicle acceleration.
Which lots are affected?
The devices in US distribution were manufactured between 29 September 2014 and 19 September 2015. Material Serialnumber 1C66=L22-2-P/0 201516011 1C66=L23-1-P/0 201525027 1C66=L23-2-P/0 201516014 201516016 201525022 1C66=L24-1-P/0 201516006 201516019 201525007 1C66=L24-2-P/0 201516002 201525012 201525020 1C66=L25-1-P/0 201449025 201518040 1C66=L25-2-P/0 201448015 201448019 201449020 201449034 201507001 201507005 201523037 1C66=L25-3-P/0 201448018 201449039 201507007 201507008 201507017 201514033 201518007 201528008 1C66=L26-1-P/0 201507006 1C66=L26-2-P/0 201444038 201444039 201444043 201444046 201444048 201449038 201507009 201507015 201507019 201528021 201528025 1C66=L26-3-P/0 201444004 201444014 201444037 201444040 201444047 201444049 201449001 201449004 201504007 201504011 201504020 201518026 1C66=L26-3-P/0 201518027 201518029 201518030 201518031 201523011 201523018 201523028 201523035 201523043 201523045 201523048 201529003 201529009 201529010 201529014 201529027 201529028 1C66=L27-2-P/0 201448012 201448020 201449008 201449013 201449027 201449030 201523027 1C66=L27-3-P/0 201444003 201444007 201444024 201444031 201444032 201444035 201444036 201444044 201449017 201449019 201449024 201449032 201449033 201504016 201504018 201504019 201504021 201504028 201518001 201518010 201518011 201518022 201518041 201523020 201528001 201528004 201528013 201528019 201528023 201529005 201529008 201529013 1C66=L27-3-P/0 201529015 201529017 201538031 1C66=L28-2-P/0 201507026 1C66=L28-3-P/0 201448022 201448023 201448027 201449037 201507027 201507028 201507029 201507030 201529040 201538014 1C66=L29-2-P/0 201507021 1C66=L29-3-P/0 201448007 201448008 201514001 201518013 201518024 201528007 201528022 201529023 201529024 1C66=R22-1-P/0 201516013 1C66=R23-1-P/0 201508008 201508020 201525039 1C66=R23-2-P/0 201508009 201508012 1C66=R24-2-P/0 201508016 201525026 1C66=R25-1-P/0 201448001 201507024 201507025 201518042 201523047 201528010 201528014 201529018 201529033 1C66=R25-2-P/0 201448006 201448009 201504004 201507032 201518016 201518043 1C66=R25-3-P/0 201448003 201448004 201448005 201504003 201504015 201504024 201514011 201514038 201518021 1C66=R25-3-P/0 201518036 201518049 201523013 201523032 201523034 1C66=R26-1-P/0 201448002 201504006 1C66=R26-2-P/0 201444002 201444008 201444025 201444028 201504009 201504013 201504026 201504027 201507016 201507023 201523024 1C66=R26-3-P/0 201448042 201448043 201448045 201448050 201504012 201504017 201504022 201504023 201504030 201507013 201507014 201507020 201518002 201518018 201518047 201523004 201523010 201523014 201523016 201523025 201523030 201523049 201523050 201529031 201529039 201538024 201538033 201538034 1C66=R27-2-P/0 201448033 201448035 201448036 201448040 201449023 201504014 201518014 201518032 201518045 201518050 1C66=R27-2-P/0 201523031 201529034 1C66=R27-3-P/0 201444010 201444015 201444016 201444017 201444023 201444027 201444029 201444034 201449005 201449009 201449021 201449026 201449031 201449035 201449040 201518017 201518023 201523003 201523005 201523006 201523017 201523026 201523033 201529019 201529045 1C66=R28-2-P/0 201507033 201510019 201518033 201523040 201529032 1C66=R28-3-P/0 201448029 201448034 201448039 201449002 201449010 201449014 201449022 201449036 201518009 201518039 201529020 1C66=R29-2-P/0 201507018 1C66=R29-3-P/0 201448041 201507010 201514002 201514020 201518037 201523038 201528009 201529002 201529026
Where was it sold?
Worldwide Distribution - US (nationwide) and to the countries of : Austria, Belgium, Germany, Israel, Luxembourg and Sweden.
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 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.
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