Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.
FDA device recall Z-1462-2012 · posted 2012-04-25 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- The monitor Ceiling suspension may fail, which may cause the monitor to drop.
- Action taken
- Philips sent an "URGENT-FIELD SAFETY NOTICE" dated March 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides information for continued safe and proper use of the equipment. Contact your local Philips representative at 866-767-2822 for further support regarding this issue. Recall expanded 5-2013 to additional 460 units distributed worldwide.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 145
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Algeria, Argentina, Belgium, Brazil, Canada, Czech Rep, Chili, China, Columbia, Denmark, Egypt, France, Germany, Indi
- Date initiated
- 2012-04-02
- Date posted
- 2012-04-25
- Date terminated
- 2014-05-09
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLURA XPER FD20 (K033737) | Philips Medical Systems North America, Inc. | 2003-12-09 |
| PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 (K031333) | Philips Medical Systems North America, Inc. | 2003-05-13 |