Philips Integris Allura Flat Detector 9C Angiographic X-ray system. This system with Velara Generator can be identified
FDA device recall Z-2477-2010 · posted 2010-09-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display.
- Action taken
- The firm, Philips, sent "URGENT-Device Correction" letters dated November 10, 2008, to their customers and informed them about the reliability issue in the Allura XPER and Integris X-ray systems with the High Voltage Velera (HV) Generator. This reliability issue can lead to a system error causing intermittent loss of fluro and/or exposure acquisition, potentially resulting in the loss of the X-ray image on the display. The customers are advised if they experience High Voltage Generator reliability issue and the HV Generator stops working generating an O3EA error, a cold restart is required and reboot the system when the X-Ray image disappears. The firm will implement multiple mandatory Field Change Orders (FCOs) to solve the Generator reliability by updating the software for each X-ray system. The customers could contact Philips Care Center at 800-722-9377, #5, #4, #1 for any questions regarding this recall or 425-487-7469.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 269 units in US
- Distribution
- Worldwide distribution.
- Date initiated
- 2008-10-23
- Date posted
- 2010-09-22
- Date terminated
- 2011-08-10
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 (K022899) | Philips Medical Systems North America Co. | 2002-11-22 |