Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-fr
FDA device recall Z-1739-2025 · posted 2025-05-08 · Open, Classified
Recall details
- Recalling firm
- WANDERCRAFT SAS
- Reason for recall
- Potential for exoskeleton to lose lateral balance and cause patient to fall.
- 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.
- Root cause
- Use error
- Status
- Open, Classified
- Product code
- PHL
- Quantity affected
- 3
- Distribution
- Domestic: PA & NY.
- Date initiated
- 2025-04-03
- Date posted
- 2025-05-08
- Location
- Paris, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Atalante (K221859) | Wandercraft SAS | 2022-12-29 |