Recall Z-1822-2017 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Electronics North America Corporation
The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010; Allura Xper FD10/10 722011; Allura Xper FD20 722012; Allura Xper FD20 biplane 722013; Allura Xper FD10 OR Table 722014; Al
| Date | Mar 22, 2017 |
| Status | Terminated |
| Reason | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire. |
| Root cause | Under Investigation by firm |
| Action | Consignees were notified of the recall via letter sent on 3/22/2017. The letter explains the issue, actions that should be taken by the customer, and actions to be taken by Philips. |
| Quantity | 6992 (total distributed for all products) |
| Distribution | Nationwide, worldwide including Canada |
| 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 |
| 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 |
| K102005 | ALLURA XPER OR TABLE SERIES Philips Medical Systems North America, Inc., Aug 9, 2010 |