Recall Z-1739-2025 ยท PHL Powered Exoskeleton
WANDERCRAFT SAS
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.
| Date | May 8, 2025 (initiated Apr 3, 2025) |
| Status | Open, Classified |
| Reason | Potential for exoskeleton to lose lateral balance and cause patient to fall. |
| Root cause | Use error |
| Action | 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. |
| Quantity | 3 |
| Distribution | Domestic: PA & NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221859 | Atalante Wandercraft SAS, Dec 29, 2022 |