FDA Recall
Terminated
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.
Recall: Z-3178-2018
·
Initiated August 15, 2018
Recall
- Recall Number
- Z-3178-2018
- Event Number
- 80686
- Firm
- Permobil, Ab Arvaltsvagen 10
- FEI Number
- 3002807844
- Product Code
- ITI
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 15, 2018
- Terminated
- May 3, 2021
- Address
- Box 120, Timra Sweden
Description
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.
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.
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.
Distribution
Worldwide Distribution - US Nationwide
Quantity
3134 units