Medical device recalls Moderate risk

WANDERCRAFT SAS recalls Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-f…

Recall date
April 3, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1739-2025
FDA classification
Class II
Brand / firm
WANDERCRAFT SAS
Sold / distributed
Domestic: PA & NY.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.

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