FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk
[RECALL]Feb 28, 2020 · ReWalk Robotics · ReWalk Personal Exoskeleton · Multiple, USA
Failure Mode
RECALL
Event Date
Feb 28, 2020
Primary Entity
ReWalk Robotics
Robotic Platform
ReWalk Personal Exoskeleton
Jurisdiction / Location
Multiple, USA
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
ReWalk Robotics initiated a Class 2 device recall on February 28, 2020, after receiving two complaints (one in the US, one in Germany) alleging that the ReWalk device waistpack containing Li-Ion battery packs caught fire while being charged. The recall affected 350 units distributed nationwide in the US. The FDA determined the cause as device design. The recall was terminated on November 10, 2021.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=187111
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=187111
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Details
Incident Context & FAQ
What happened in FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk?
ReWalk Robotics initiated a Class 2 device recall on February 28, 2020, after receiving two complaints (one in the US, one in Germany) alleging that the ReWalk device waistpack containing Li-Ion battery packs caught fire while being charged. The recall affected 350 units distributed nationwide in the US. The FDA determined the cause as device design. The recall was terminated on November 10, 2021.
When did this incident occur?
The incident is recorded as occurring on February 28, 2020 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk?
ReWalk Personal Exoskeleton by ReWalk Robotics is the recorded robot involved in this incident at Multiple, USA.
Has anyone responded to FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.