Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115.
Recall
- Recall Number
- Z-1657-2011
- Event Number
- 57777
- Firm
- Philips Medical Systems North America Co. Phillips
- FEI Number
- 1000524572
- Product Code
- IZI
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 7, 2010
- Posted
- March 16, 2011
- Terminated
- February 23, 2012
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431
Description
Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115.
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.
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 Eleva, and OmniDiagnost Eleva Imaging system. Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
Devices were distributed through out the US.
16 units distributed in US