Allura XPER 10/10
FDA device recall Z-0344-2009 · posted 2009-09-24 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Action taken
- 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, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 104 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2008-12-10
- Date posted
- 2009-09-24
- Date terminated
- 2012-08-17
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 (K031333) | Philips Medical Systems North America, Inc. | 2003-05-13 |
| RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS (K984545) | Philips Medical Systems North America, Inc. | 1999-02-25 |