Haifahaifa, Israel
Argo Medical Technologies Ltd recalls
2 recalls recorded since 2018, most recently on 28 February 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 28 February 2020
- Terminated
- 10 November 2021
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1553-2021
- 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 am
Terminated Class II Medical devices
- Recall started
- 14 August 2017
- Terminated
- 12 November 2019
- Reason
- Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.
- Distribution
- US and foreign.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0944-2018
- ReWalk Personal 6.0. Catalog number: 50-20-0004.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.