[pending] Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobili
Pending LLM rewrite. Source: FDA_DEVICE Z-1739-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential for exoskeleton to lose lateral balance and cause patient to fall.
The recalled product
- 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.
- Manufacturer
- WANDERCRAFT SAS
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 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.
Distribution
Distributed in 2 states:
- NY
- PA
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