Recall Z-0329-2008 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021
| Date | Dec 7, 2007 (initiated Sep 24, 2007) |
| Status | Terminated |
| Reason | Inaccurate anatomical measurements when using the optional SmartMask feature |
| Root cause | Device Design |
| Action | The recalling firm sent customers an Urgent Device Correction notification letter dated 09/21/07 via certified mail - return receipt requested. This notification provided a short term work around for the device defect. For a permanent fix, the recalling firm is developing software update to check for mismatch at the start of a subtracted fluoroscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/2007 and be completed 06/2008. |
| Quantity | 468 units |
| Distribution | Nationwide |
| 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 |