Recall Z-1739-2025— WANDERCRAFT SAS
Class II · Ongoing
Class II FDA medical device recall by WANDERCRAFT SAS, initiated 2025-04-03. It names one FDA 510(k) clearance: K221859. 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.. Reason: Potential for exoskeleton to lose lateral balance and cause patient to fall..
- Recalling firm
- WANDERCRAFT SAS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-03
- Firm location
- Paris, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.