PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: May 14, 2025 Initiated: April 3, 2025 #Z-1739-2025

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.

Details

Recalling Firm
WANDERCRAFT SAS
Units Affected
3
Distribution
Domestic: PA & NY.
Location
Paris, N/A

Frequently Asked Questions

What product was recalled?
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.. Recalled by WANDERCRAFT SAS. Units affected: 3.
Why was this product recalled?
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 14, 2025. Severity: Moderate. Recall number: Z-1739-2025.