iOS Galileo Application Version 1 — Class II medical device recall Z-0209-2016
Terminated recall by Otto Bock Healthcare GmbH, reported 2015-11-11, distributed nationwide. A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. When sitting
| Recall number | Z-0209-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Otto Bock Healthcare GmbH, Duderstadt, N/A, Germany |
| Recall initiated | 2015-10-23 |
| Classified | 2015-11-05 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2017-03-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, DE, IL, LU, SE |
| Reason classes | software |
| Serial numbers | 201444002, 201444003, 201444004, 201444007, 201444008, 201444010, 201444014, 201444015, 201444016, 201444017, 201444023, 201444024, 201444025, 201444027, 201444028, 201444029, 201444031, 201444032, 201444034, 201444035, 201444036, 201444037, 201444038, 201444039, 201444040 and 248 more |
Product
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0209-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.