OEC FluoroTrak 9800 PLUS, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
This recall has been terminated (originally issued September 28, 2007).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- March 1, 2007
- Posted
- September 28, 2007
- Terminated
- May 1, 2012
- Recall Number
- Z-0680-2007
- Quantity
- 5 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
During routine service, primary and/or secondary collimators may not have been properly reinstalled.
Distribution
Nationwide and Germany.
Lot / Code Info
Serial numbers: 89-1579-N, 89-2529-N, 82-2160-N, 8S-1932-N, 8S-2226-N.
Root Cause
Other
Action Taken
Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.
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