ReWalk Robotics Recalls Powered Exoskeletons Due to Fire Risk
Argo Medical Technologies is recalling ReWalk Personal and R Systems exoskeletons after reports that the waistpack battery packs caught fire while charging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a fire hazard in a medical device, which constitutes a significant injury risk. Per the rubric, significant injury or property-damage reports (fire) align with a Severe (4) classification.
Plain-English summary
Argo Medical Technologies Ltd is recalling 350 units of ReWalk Personal 6.0, ReWalk Personal 5.0, and ReWalk R Systems powered exoskeletons. These devices are intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions. The recall covers all serial numbers and affects units distributed nationwide in the United States.
The recall was initiated after ReWalk Robotics received two complaints alleging that the device's waistpack, which houses the Li-Ion battery packs, caught fire while being charged. One complaint originated in the United States and the other in Germany.
Consumers who possess these devices should stop using them immediately and contact Argo Medical Technologies for instructions on how to proceed with the recall.
The recalled product
- Product
- ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.
- Manufacturer
- Argo Medical Technologies Ltd
- Hazard
- Affected units
- 350
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 (1)
- All Serial numbers
Distribution
Distributed nationwide across the United States.
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