FDA Device recall Z-1553-2021
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 intend…
- FDA Device
- Class II
- terminated
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of 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 intend… by Argo Medical Technologies, citing 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) cau….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1553-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-28 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Argo Medical Technologies |
| Distribution | US |
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.
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.
Identifiers
| code_info | All Serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1553-2021%22
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