Recall Z-0006-2018 ยท ITI Wheelchair, Powered
Permobil, Ab
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
| Date | Oct 3, 2017 (initiated Sep 1, 2017) |
| Status | Terminated |
| Reason | There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base. |
| Root cause | Device Design |
| Action | The firm initiated the recall by letter on 09/01/2017. The distributor/dealers were instructed as follows: LOG INTO CORRECTION WEB PORTAL Immediately log into www.permobilfsa.com. Log in with the following ID and Password. CEASE DISTRIBUTION OF EXISTING INVENTORY Please examine your inventory for the serial numbers assigned to you, cease distribution, and quarantine those chairs. IMMEDIATELY PERFORM INSPECTION If you have distributed these serial numbers to end users, you must immediately contact them to perform a visual inspection of the top plate assembly looking for obvious si |
| Quantity | 146 units |
| Distribution | Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE |
| FDA record | Open on fda.gov |