FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1739-2025
·
Reported May 14, 2025
Enforcement
- Recall Number
- Z-1739-2025
- Event ID
- 96635
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- WANDERCRAFT SAS
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 14, 2025
- Initiation Date
- April 3, 2025
- Classification Date
- May 8, 2025
- Address
- 88 Rue De Rivoli, N/A, Paris, N/A, N/A, France
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.
Reason
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Code Info
UDI: (01)3665965000129(21)V5_ABP(11)AA06JJ, (01)3665965000129(21)V5_ACH(11)AA09JJ, (01)3665965000129(21)V5_ADO(11)AA02JJ. No model or serial number.
Distribution
Domestic: PA & NY.
Quantity
3