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Triton Smart Ankle (2015-10-29)
- Starting date:
- October 29, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55854
Affected Products
Triton Smart Ankle
Reason
When sitting, the prosthetic foot can go into the 'relief function' and move the footplate towards the ground if this function is not switched off or if the foot is in stand-by mode.
When operating machines with foot pedals, the possibility is given that the foot - unnoticed by the user - activates the 'relief function' and for example get stuck under the foot pedal. The foot pedal can be blocked and this could lead to a hazardous situation.
Also, an iOS software issue has been identified where the restricted range for dorsiflexion in the 'relief function' does not save when the re-training is done via iOS Galileo application.
Affected products
Triton Smart Ankle
Lot or serial number
Not applicable
Model or catalog number
1C66*
Companies
- Manufacturer
-
Otto Bock Healthcare GMBH
MAX NADER STRABE 15
DUDERSTADT
37115
GERMANY