# FDA recall Z-1553-2021

> **Argo Medical Technologies Ltd** · Class II · device recall initiated 2020-02-28.

## 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.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1553-2021
- **Recalling firm:** Argo Medical Technologies Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-28
- **Report date:** 2021-05-19
- **Termination date:** 2021-11-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Haifahaifa, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1553-2021

## Citation

> AI Analytics. FDA recall Z-1553-2021. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1553-2021. Source: US FDA. Licensed CC0.

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