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.
This recall is currently active, issued May 8, 2025. It was issued by Wandercraft Sas.
- Company
- Wandercraft Sas
- Recall Initiated
- April 3, 2025
- Posted
- May 8, 2025
- Recall Number
- Z-1739-2025
- Quantity
- 3
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Distribution
Domestic: PA & NY.
Lot / 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.
Root Cause
Use error
Action Taken
An URGENT SAFETY NOTICE dated 4/3/25 was mailed to consignees. The letter notifies consignees that WANDERCRAFT will be reinforcing their training program for the Atalante X and providing additional instructions by 5/1/25. Until the additional instructions can be provided, users are being instructed to only have certified Atalante X operators maintain the stability of the exoskeleton at all times by keeping at least one hand on the handles throughout the session. Consignees are to share the recall notification with users at their facility and retained for awareness.