OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
Recall
- Recall Number
- Z-1865-2012
- Event Number
- 62016
- Firm
- GE OEC Medical Systems, Inc
- FEI Number
- 1720753
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 20, 2006
- Posted
- June 22, 2012
- Terminated
- June 25, 2012
- Address
- 384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862
Description
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
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.
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.
Worldwide Distribution.
717 units