Recall Z-0165-2007 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Allura X-per FD 10/10 x-ray, and fluoroscopy
| Date | Nov 14, 2006 (initiated Oct 12, 2006) |
| Status | Terminated |
| Reason | Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue. |
| Root cause | Other |
| Action | On 10/12/06 the firm issued a letter to their consignees advising of the problem and how to avoid the problem by using specific image formats. If the system should lock up, consignees are to switch the system off and then restart. The firm will be conducting software upgrades to the devices once software is ready (estimated time for FD 10/10 is November 2006 and estimated time for FD 20/10 is January 2007). Later, the firm identified 8 additional units and issued a letter on 12/11/06 to affected customers. |
| Quantity | 47 devices |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031333 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 Philips Medical Systems North America, Inc., May 13, 2003 |