Class 2 Device Recall ReWalk

• Date Initiated by Firm: February 28, 2020
• Create Date: May 11, 2021
• Recall Status: Terminated on November 10, 2021
• Recall Number: Z-1553-2021
• Recall Event ID: 87818
• 510(K)Number: K160987 K200032
• Product Classification: Powered Exoskeleton - Product Code PHL
• Product: 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.
• Code Information: All Serial numbers
• Recalling Firm/ Manufacturer: Argo Medical Technologies Ltd; Matambuilding 30p.O.Box 15054; Haifahaifa Israel
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• 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
• Quantity in Commerce: 350 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PHL and Original Applicant = REWALK ROBOTICS INC.; 510(K)s with Product Code = PHL and Original Applicant = ReWalk Robotics Ltd.