Recall Z-0124-2011 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.
| Date | Oct 22, 2010 (initiated Aug 21, 2008) |
| Status | Terminated |
| Reason | Due to a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible. |
| Root cause | Software design |
| Action | Philips Medical Systems North America Co. sent an URGENT - Device Correction, dated September 15, 2010, to their consignees. The letter identified the product, the problem, and the action to be taken. The consignees were informed that there was a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible. The consignees were advised that as geometry software errors happen intermittently, no actions can be performed by the consignees to minimize the risk except for not performing DRA procedures until the firm |
| Quantity | 47 units |
| Distribution | Devices were distributed to hospitals and medical facilities through out the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041949 | ALLURA XPER FD10 Philips Medical Systems North America Co., Jul 30, 2004 |