iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.

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.

OttoBock sent an Urgent Medical Device Correction letter dated October 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The US Agent will notify US customers via letter on October 23, 2015, of the correction on behalf of the Manufacturer. Customers will be requested to contact all users and advise them of the hazards when operating machines or vehicles with foot pedals. They may forward a copy of the insert if needed. Customers will also be requested to contact all users with TF-fittings, where the settings were done via iOS Galileo app., inform the user about this issue, and assure that settings in the device are as expected.The customer will be requested to complete a reply form and return to the US Agent. For further questions call (800) 328-4058.