FDA Recall
Terminated
GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.
Recall: Z-0041-2007
·
Initiated September 13, 2006
Recall
- Recall Number
- Z-0041-2007
- Event Number
- 36400
- Firm
- GE OEC Medical Systems, Inc
- FEI Number
- 1720753
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 13, 2006
- Posted
- October 25, 2006
- Terminated
- August 13, 2009
- Address
- 384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862
Description
GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.
Reason
Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy.
Action
Consignees will be notified by letter beginning 10/16/2006.
Distribution
FL, GA, IL, IN, LA, MA, MD, MO, NH, NJ, PA, TX, UT. Includes one VA facility in PA. China, France.
Quantity
40 units