FDA-Device2021-05-19Class II
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.
Argo Medical Technologies Ltd
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.
Sold states
US Nationwide distribution.
Affected count
350 units
Manufactured in
Matambuilding 30p.O.Box 15054, Haifahaifa, Israel
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1553-2021Don't want to check this manually?
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