Recall Z-1553-2021— Argo Medical Technologies Ltd
Class II · Terminated
Class II FDA medical device recall by Argo Medical Technologies Ltd, initiated 2020-02-28, terminated 2021-11-10. It names 2 FDA 510(k) clearances: K200032, K160987. 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: 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..
- Recalling firm
- Argo Medical Technologies Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-28
- Terminated
- 2021-11-10
- Firm location
- Haifahaifa, Israel
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.