Recall Z-1553-2021 ยท PHL Powered Exoskeleton
Argo Medical Technologies Ltd
ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.
| Date | Feb 28, 2020 |
| Status | Terminated |
| Reason | ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caught fire while being charged. |
| Root cause | Device Design |
| Action | Rewalk issued Customer Communication Letter - Proper Operation and Storage of the ReWalk System Batteries to ReWalk System Owners, Companions, Distributors and ReWalk Certified Physiotherapists via certified Mail on 2/28/20. Letter states reason for recall, health risk and action to take: " General: o Do not charge the batteries while wearing the device. o If the battery usage time becomes much shorter than usual, contact your ReWalk representative. o Do not store, charge or use the system in an environment where the ambient temperatures may be higher than 113 Fahrenheit (45 Celsius) or lower |
| Quantity | 350 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |