ReWalk Personal 6 recalled over fire hazard

Recall date

February 28, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 uppe…

Recall number

Z-1553-2021

FDA classification

Class II

Brand / firm

Argo Medical Technologies Ltd

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.