BEUDAMED
    FDA Recall 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 · Initiated February 28, 2020

    Recall

    Recall Number
    Z-1553-2021
    Event Number
    87818
    Firm
    Argo Medical Technologies Ltd Matambuilding 30p.O.Box
    FEI Number
    3007615665
    Product Code
    PHL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 28, 2020
    Terminated
    November 10, 2021
    Address
    15054 Haifahaifa 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.

    Action

    Rewalk issued Customer Communication Letter - Proper Operation and Storage of the ReWalk System Batteries to ReWalk System Owners, Companions, Distributors and ReWalk Certified Physiotherapists via certified Mail on 2/28/20. Letter states reason for recall, health risk and action to take: " General: o Do not charge the batteries while wearing the device. o If the battery usage time becomes much shorter than usual, contact your ReWalk representative. o Do not store, charge or use the system in an environment where the ambient temperatures may be higher than 113 Fahrenheit (45 Celsius) or lower than 32 Fahrenheit (0 Celsius). o Improper handling of the ReWalk Main and Aux rechargeable batteries may cause chemical leakage, heat, smoke, fire, or an explosion. " During System Charging: o When connecting the charger to the system, make sure the connector is securely screwed in place. o Do not charge the batteries continuously for more than 8 hours. If the battery is not fully charged after 8 hours - discontinue charging, stop the usage of the system and call your ReWalk Service representative. o Make sure to fully charge the system after each use. o The system is fully charged when the charger LEDs are Green. o Do not charge the system if the charger LEDs are flashing - discontinue charging, stop the usage of the system and call your ReWalk Service representative. " Charging Before System Storage: o Short term storage (7 days or less) The system must be fully charged before storage. The ReWalk system should be fully charged at least once a week. o Long term storage (more than 7 days) Fully charge the system before storage, then turn off the system, open the waistpack and disconnect the Main and Aux battery plugs (refer to the relevant steps in the User Guide). For first use after storage connect the plugs, close the waistpack and charge the system until the charger LEDs are Green. Do not charge the batteries for more than 8 hours

    Distribution

    US Nationwide distribution.

    Quantity

    350 units