Drug recall
ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of…
FDA recall event 87818 · Class II · Argo Medical Technologies Ltd
Key facts
| Event ID | 87818 |
|---|---|
| Recall numbers | Z-1553-2021 |
| Recalling firm | Argo Medical Technologies Ltd |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 28, 2020 |
| Report date | May 19, 2021 |
| Termination date | Nov 10, 2021 |
| City | Haifahaifa |
| Country | Israel |
| FEI number | 3007615665 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: