FDA recall Z-1739-2025

WANDERCRAFT SAS · Class II · device

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 for recall

Potential for exoskeleton to lose lateral balance and cause patient to fall.

Distribution

Domestic: PA & NY.

Key facts

Status: Ongoing
Initiation date: 2025-04-03
Report date: 2025-05-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Paris, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1739-2025