Recall Z-1462-2012 ยท IZI System, X-Ray, Angiographic
Philips Healthcare Inc.
Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.
| Date | Apr 25, 2012 (initiated Apr 2, 2012) |
| Status | Terminated |
| Reason | The monitor Ceiling suspension may fail, which may cause the monitor to drop. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 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, India, Indonesia, Italy, Japan, Malaysia, Mexico, Morocco, Netherlands, Oman, Russia, Saudi Arabia, Sing |
| FDA record | Open on fda.gov |