Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iOS Galileo Application Version 1.1.1 or lower that programs the Recalled by Otto Bock Healthcare GmbH Due to A software issue can make the foot move...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Otto Bock Healthcare GmbH directly.
Affected Products
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
Quantity: 273 in US: 48 Foreign
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Otto Bock Healthcare GmbH
Otto Bock Healthcare GmbH has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report