Argo Medical Technologies Ltd Recall 87818
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.
Argo Medical Technologies Ltd Recall 87818 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1553-2021 |
| Event ID | 87818 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 350 units |
| Recall 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. |
| Device Classification | 20210519 |
| Device Code Info | All Serial numbers |
| Center Classification Date | 20210511 |
| Recall Initiation Date | 20200228 |
| Recalling Firm | Argo Medical Technologies Ltd |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Similar To |