11

Nov

2015

Cl II Triton Smart Ankle iOS Galileo applcation

0

Company: Otto Bock Healthcare GmbHG
Date of Enforcement Report 11/11/2015
Class lI:

PRODUCT

iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66* Triton Smart Ankle. Recall Number Z-0209-2016

REASON
Otto Bock Healthcare GmbH has identified a software issue where the foot can produce an undesired response (can move into dorsiflexion) unnoticed by the user. This could potentially result in a fall. In addition, when sitting, the prosthetic foot 1C66 Triton smart ankle can go into the so called Relief Function to move the footplate towards the ground. When operating machines with foot pedals (e.g. driving a car) the possibility exists that the foot could get stuck under the foot pedal and block it or, if the foot is on top of the pedal, it could cause the vehicle to accelerate unintentionally, leading to a hazardous situation.

RECALLING FIRM/MANUFACTURER
Otto Bock Healthcare GmbH, Duderstadt, DE on 10/23/2015 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
273 in US: 48 Foreign

DISTRIBUTION
Worldwide Distribution – US (nationwide) and to the countries of : Austria, Belgium, Germany, Israel, Luxembourg and Sweden.

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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