Recall
ReWalk Personal 6.0. Catalog number: 50-20-0004.
Argo Medical Technologies Ltd · 14 Aug 2017
- Status
- Recall terminated
- Why, in the FDA's words
- “Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.”
- Recall began
- 14 Aug 2017
- Company
- Argo Medical Technologies Ltd
- Device type
- Powered exoskeletons (PHL)
- Concerns
- K160987
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.