Recall Z-0349-2009 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Allura XPER FD20
| Date | Sep 24, 2009 (initiated Dec 10, 2008) |
| Status | Terminated |
| Reason | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200 |
| Quantity | 835 units |
| Distribution | Worldwide Distribution |
| 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 |