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