OEC 9800 Plus Fluoroscopic X-ray System,
This recall has been terminated (originally issued March 22, 2007).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- February 9, 2007
- Posted
- March 22, 2007
- Terminated
- June 26, 2007
- Recall Number
- Z-0558-2007
- Quantity
- 11 units of all models
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
During routine service, a cover may have been installed without the required proper lead shielding.
Distribution
Nationwide to AL, AZ, IA, OH, TX, VA, and WV.
Lot / Code Info
Serial numbers: 82-7092-MH, 89-0247-RC, 89-0599, 89-0972, 89-1001, 89-1685, 89-2383, 89-2877, 89-2907, 89-2987, 89-3330.
Root Cause
Other
Action Taken
Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.
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