Recall Z-0209-2016— Otto Bock Healthcare GmbH
Class II · Terminated
Class II FDA medical device recall by Otto Bock Healthcare GmbH, initiated 2015-10-23, terminated 2017-03-21. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Otto Bock Healthcare GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-23
- Terminated
- 2017-03-21
- Firm location
- Duderstadt, N/A, Germany
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.