Recall Z-0581-06 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Allura Xper FD10/10 x-ray system
| Date | Feb 28, 2006 (initiated Feb 6, 2006) |
| Status | Terminated |
| Reason | Potential lock-up of system requiring reboot of system. |
| Root cause | Other |
| Action | On 2/6/06 the firm sent a Product Safety Notification letter to the customers that have devices installed. The letter advises of the problem, and to restart the device if it locks up. The letter also states that the firm will be performing upgrades of the devices. |
| Quantity | 55 devices total (Allura Xper FD10/10 & Allura Xper FD10) |
| Distribution | Nationwide. Devices were distributed to 42 hospitals/medical centers (35 customers have devices set up) throughout the USA. |
| 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 |