WANDERCRAFT SAS: Device Recall
Recall #Z-1739-2025 · 04/03/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1739-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- WANDERCRAFT SAS
- Status
- Ongoing
- Date Initiated
- 04/03/2025
- Location
- Paris, N/A, France
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Reason for Recall
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Product Description
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.
Distribution Pattern
Domestic: PA & NY.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.