Recall Z-0370-2007 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector
| Date | Jan 25, 2007 (initiated Dec 14, 2006) |
| Status | Terminated |
| Reason | Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested. |
| Root cause | Other |
| Action | On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service. |
| Quantity | 140 devices total |
| Distribution | Units were distributed to hospitals and medical centers 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 |