Atalante X Powered Exoskeleton Lateral Balance Loss Recall
WANDERCRAFT SAS is recalling the Atalante X powered exoskeleton due to a potential loss of lateral balance that could cause patients to fall. Three units have been distributed to rehabilitation facilities in Pennsylvania and New York.
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: This is an FDA Class II recall involving a risk-of-harm medical device (fall risk due to loss of lateral balance) where no injuries have been reported in the source text. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
WANDERCRAFT SAS is recalling the Atalante X powered exoskeleton, a device intended to perform ambulatory functions and mobility exercises in rehabilitation institutions under trained operator supervision.
The device has a potential for loss of lateral balance, which could cause a patient to fall. This recall affects three units that have been distributed domestically to Pennsylvania and New York.
Rehabilitation facilities and healthcare providers in possession of an Atalante X exoskeleton should contact the manufacturer, WANDERCRAFT SAS, regarding this recall. The affected units can be identified by their UDI codes: (01)3665965000129(21)V5_ABP(11)AA06JJ, (01)3665965000129(21)V5_ACH(11)AA09JJ, and (01)3665965000129(21)V5_ADO(11)AA02JJ.
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
- Hazard
- fall-risk
- balance-loss
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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