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Otto Bock Healthcare GmbH recalls iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an externa
Recalled November 11, 2015 · FDA recall Z-0209-2016 · Otto Bock Healthcare
Hazard
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. · FDA Class II
Units
273 in US: 48 Foreign
Sold at
Worldwide Distribution - US (nationwide) and to the countries of : Austria, Belgium, Germany, Israel, Luxembourg and Sweden.
Description
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.
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.
Manufacturer(s)
Otto Bock Healthcare GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →