Recall Z-0206-06 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
AD5 table for use with Integris and Integris Allura x-ray systems
| Date | Nov 29, 2005 (initiated Oct 12, 2005) |
| Status | Terminated |
| Reason | Potential for high voltage exposure involving the injector interface connector of patient support tables. |
| Root cause | Other |
| Action | On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units. |
| Quantity | 1770 units with AD5 tables |
| Distribution | Devices were distributed nationwide to hospitals/medical centers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002016 | PHILIPS INTEGRIS ALLURA Philips Medical Systems North America, Inc., Sep 6, 2000 |
| K020055 | PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION Philips Medical Systems, Mar 15, 2002 |
| K031333 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 Philips Medical Systems North America, Inc., May 13, 2003 |
| K925302 | PHILIPS INTEGRIS H/HM SYSTEM Philips Medical Systems, Inc., Dec 17, 1992 |
| K984545 | RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS Philips Medical Systems North America, Inc., Feb 25, 1999 |