Recall Z-3178-2018 ยท ITI Wheelchair, Powered
Permobil, Ab
Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchair.
| Date | Aug 15, 2018 |
| Status | Terminated |
| Reason | This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury. |
| Root cause | Device Design |
| Action | The firm initiated the recall on 08/15/2018 by letter to the direct accounts (dealer/distributors). The letter instructed the consignee to contact the end users and perform the correction. |
| Quantity | 3134 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |