Recall Z-1657-2011 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115.
| Date | Mar 16, 2011 (initiated Oct 7, 2010) |
| Status | Terminated |
| Reason | A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees. The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available). The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost |
| Quantity | 16 units distributed in US |
| Distribution | Devices were distributed through out the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032046 | PHILLIPS OMNIDIAGNOST ELEVA Philips Medical Systems, Inc., Jul 17, 2003 |