Recall
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
WANDERCRAFT SAS · 3 April 2025
- Status
- Recall open, classified
- Why, in the FDA's words
- “Potential for exoskeleton to lose lateral balance and cause patient to fall.”
- Recall began
- 3 April 2025
- Company
- WANDERCRAFT SAS
- Device type
- Powered exoskeletons (PHL)
- Concerns
- K221859
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.