OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
This recall has been terminated (originally issued September 1, 2008).
- Company
- Oec Medical Systems, Inc
- Recall Initiated
- April 15, 2008
- Posted
- September 1, 2008
- Terminated
- December 21, 2011
- Recall Number
- Z-1706-2008
- Quantity
- 25 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Use of existing four-pedal footswitch on a different machine may cause various operational errors.
Distribution
Nationwide, including one VA facility in FL. No military or foreign distribution.
Lot / Code Info
Serial numbers: E2-0034, E2-0088, E2-0109, E2-0258, E2-0270, E2-7019-MH, E2-7020-MH, E2-7034-CMH, E2-7037-MH, E2-7043-MH, E9-0029, E9-0047, E9-0169, E9-0171, E9-0172, E9-0173, E9-0177, ES-0113, ES-7015-MH.
Root Cause
Device Design
Action Taken
Consignees were notified by letter on 03/21/2007 and advised that GE would be replacing the 4-pedal switches at some time in the future. Replacement began on 04/15/2008. Contact GE Healthcare at 1-800-874-7378 for assistance.
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