Z-1553-2021 Class II Terminated
FDA device recall Z-1553-2021 was initiated by Argo Medical Technologies Ltd on February 28, 2020 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated November 10, 2021). Affected quantity: 350 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- February 28, 2020
- Termination Date
- November 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 350 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
All Serial numbers