OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during dia
FDA device recall Z-1865-2012 · posted 2012-06-22 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- 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 mode" and "digital spot mode", and the system does not reboot.
- Action taken
- On 11/20/06 two written notifications were sent to consignees addressed to the Facility Administrator and the Radiology Administrator. The notifications advised them that GE Healthcare had identified several intermittent potential safety issues that may occur with the product. Interim solutions were provided for each issue. The letter stated that GEHC OEC would contact customers and remedy the issues free of charge when a permanent solution became available. An Urgent Recall Notice, dated April 13, 2007, was also sent to customers. Customers were to contact the service team at 800-874-7378 for further information, if there were any questions or concerns.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 717 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2006-11-20
- Date posted
- 2012-06-22
- Date terminated
- 2012-06-25
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UROVIEW 2800 (K993687) | Ge Dec Medical Systems | 1999-12-21 |