GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
This recall has been terminated (originally issued June 30, 2007).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- June 12, 2007
- Posted
- June 30, 2007
- Terminated
- November 1, 2011
- Recall Number
- Z-0852-2007
- Quantity
- 25 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
Distribution
Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the UK.
Lot / Code Info
Serial numbers: P4-0665-R, P4-0666-L, P4-0679-R, P4-0685-L, P4-0686-L, P4-0694-R, P4-0696-L, P4-0701-R, P4-0702-R, P4-0717-L, P4-0723-R, P4-0730-L, P6-0695-R, P6-0699-R, P6-0700-R, P6-0709-R, P6-0711-L, P6-0712-R, P6-0714-L, P6-0715-L, P6-0718-R, P6-0719-L, P6-0721-L, P6-0724-R, P6-0726-L.
Root Cause
Other
Action Taken
Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems.