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Argo Medical Technologies Ltd recalls ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper
Recalled May 19, 2021 · FDA recall Z-1553-2021 · Argo Medical Technologies
Hazard
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. · FDA Class II
Units
350 units
Sold at
US Nationwide distribution.
Description
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.
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(s)
Argo Medical Technologies Ltd
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →