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Argo Medical Technologies Ltd Recall 87818

Description: 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 Recall 87818 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-1553-2021
Event ID87818
Event DescriptionReWalk 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.
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity350 units
Recall ReasonReWalk 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.
Device Classification20210519
Device Code InfoAll Serial numbers
Center Classification Date20210511
Recall Initiation Date20200228
Recalling FirmArgo Medical Technologies Ltd
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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