Recall Z-0785-2013 ยท IOR Wheelchair, Mechanical
Invacare Corporation
Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
| Date | Feb 4, 2013 (initiated Sep 10, 2012) |
| Status | Terminated |
| Reason | The potential exists for the wheel to rotate freely despite engagement of hub brake. |
| Root cause | Process control |
| Action | Invacare sent an URGENT: RECALL INFORMATION Letter dated September 10, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1) Complete the Provider Response Card indicating your receipt and understanding of these instructions. 2) Contact your customers to inform them of the recall. It is recommended that you provide them with the enclosed Customer Letter. Set up an appointment to correct the customer's wheelchair as soon as possible. 3) Please examine the wheelchair to confirm it has one of the se |
| Quantity | 3 units |
| Distribution | US Nationwide Distribution including the states of CA & MT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984447 | MODEL ACTION AT II MANUAL WHEELCHAIR Invacare Corp., Jan 8, 1999 |