Device product
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.
Z-1553-2021
Product summary
- Event
- Event 87818
- Status
- Terminated
- Classification
- Class II
- Quantity
- 350 units
- Official record key
device-enforcement:Z-1553-2021
Official wording
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.
Code information: All Serial numbers
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.