Z-1739-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2025
- Initiation Date
- April 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
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.
Reason for Recall
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Distribution Pattern
Domestic: PA & NY.
Code Information
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.