Recall Z-0161-2007 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Allura Xper FD 10/10 x-ray, angiographic system
| Date | Nov 8, 2006 (initiated Aug 24, 2006) |
| Status | Terminated |
| Reason | Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned. |
| Root cause | Other |
| Action | A letter dated September 1, 2006 was sent to customers on September 5, 2006. The letter advised customers of the problem and advised a service representative will visit the consignee to install a new software upgrade. |
| Quantity | 90 total devices - FD 10/10 & FD 10 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041949 | ALLURA XPER FD10 Philips Medical Systems North America Co., Jul 30, 2004 |