medical Class II Updated 2021-05-19

Argo Medical Technologies Ltd recalls ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R System

Recalled 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 / Issue

ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caught fire while being charged.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Serial numbers
View official government recall

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