The Recall Desk
SevereFDA (Devices)·Z-1553-2021·Announced 2021-05-19

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
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.

Same manufacturer · Argo Medical Technologies Ltd

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