OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to
FDA device recall Z-2065-2012 · posted 2012-07-24 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod
- Action taken
- Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE Healthcare sent two Urgent Recall Notice letters to the Facility Administrator and the Radiology Administrator. The letters identified the affected product, problem and actions to be taken. The letters advised consignees that GE Healthcare is actively working on solutions that will permanently resolve each of the issues. For questions or concerns contact GE Healthcare service team at 800-874-7378 option 8.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OXO
- Quantity affected
- 1257 units (472 domestic systems)
- Distribution
- Worldwide Distribution - US Nationwide
- Date initiated
- 2006-11-20
- Date posted
- 2012-07-24
- Date terminated
- 2013-05-13
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM (K003837) | Ge Oec Medical Systems | 2001-03-12 |