Recall Z-1478-2008 ยท CCX Support, Patient Position
Allen Medical Systems, Inc.
Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery.
| Date | Aug 20, 2008 (initiated Nov 27, 2007) |
| Status | Terminated |
| Reason | Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury. |
| Root cause | Device Design |
| Action | Allen Medical notified accounts by telephone on 11/08/07 and the Sales Representative. The Hospitals confirmed that the device would be sent back for evaluation and upgraded. |
| Quantity | 2 |
| Distribution | MA, MS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.