Z-1553-2021Class II

ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part...

Name: Z-1553-2021 ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part...
Creator: Argo Medical Technologies Ltd
Published: 2020-02-28
License: https://open.fda.gov/license/

Lifeward, Inc. / initiated 2020-02-28 / Terminated / root cause: design

FDA source

Argo Medical Technologies Ltd began a recall of 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... on 2020-02-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1553-2021
Classification: Class II
Status: Terminated
Initiated: 2020-02-28
Posted: 2021-05-11
Terminated: 2021-11-10
Recalling firm: Lifeward, Inc.
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.
Product code: PHL Powered Exoskeleton
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.
Root cause tag: design
FDA root 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.
Product codes and lots: All Serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1553-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1553-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-11

Product code PHL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)