Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185.
FDA device recall Z-1655-2011 · posted 2011-03-16 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 1078 units distributed in US (1102 +24-48=1078)
- Distribution
- Devices were distributed through out the US.
- Date initiated
- 2010-10-07
- Date posted
- 2011-03-16
- Date terminated
- 2012-02-23
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS (K984545) | Philips Medical Systems North America, Inc. | 1999-02-25 |