BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-1553-2021 · Reported May 19, 2021

    Enforcement

    Recall Number
    Z-1553-2021
    Event ID
    87818
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Argo Medical Technologies Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 19, 2021
    Initiation Date
    February 28, 2020
    Classification Date
    May 11, 2021
    Termination Date
    November 10, 2021
    Address
    Matambuilding 30p.O.Box 15054, Haifahaifa, N/A, Israel

    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.

    Reason

    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.

    Code Info

    All Serial numbers

    Distribution

    US Nationwide distribution.

    Quantity

    350 units