Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mob...

FDA Recall #Z-1739-2025 — Class II — April 3, 2025

Recall #Z-1739-2025 Date: April 3, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

WANDERCRAFT SAS — Paris, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3

Distribution

Domestic: PA & NY.

Code Information

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.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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