FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1739-2025
- Recalling firm
- WANDERCRAFT SAS
- Product
- 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.
- Status
- Open, Classified
- Initiated
- 2025-04-03
- Posted
- 2025-05-08
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K221859"]
- PMA numbers
- not on file
- Product code
- PHL
- Firm FEI
- 3015000676
- Firm city
- Paris
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28