Recall Z-0810-2016 ยท IZI System, X-Ray, Angiographic
Philips Electronics North America Corporation
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20; 722008 Allura Xper FD20 Biplane; 722010 Allura Xper FD10; 722011 Allura Xper FD10/10; 722012 Allura Xper FD20; 722013 Al
| Date | Feb 16, 2016 (initiated Jul 6, 2015) |
| Status | Terminated |
| Reason | The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position. |
| Root cause | Process control |
| Action | Philips sent a Field Safety Notice to all affected customers on July 6, 2015. The notice informs consignees of the reason for recall and actions to be taken by the customer/user. On September 15, 2015, Philips plans to issued a mandatory Field Safety Corrective action (FCO72200280) via Certified Return Receipt. This corrective action is the replacement of the affected MCS actuator. For further information, contact your local representative: Technical Support Line: 1-800-722-9377. |
| Quantity | 3158 devices |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of : Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033737 | ALLURA XPER FD20 Philips Medical Systems North America, Inc., Dec 9, 2003 |
| K041949 | ALLURA XPER FD10 Philips Medical Systems North America Co., Jul 30, 2004 |
| K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES Philips Medical Systems Nederland B.V., May 21, 2013 |