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On Friday, January 12, 2007, we announced that we entered into a Consent Decree of Injunction with the U.S. Food and Drug Administration (FDA) regarding GE OEC’s surgical imaging products and the OEC facilities in Salt Lake City, Utah, and Lawrence, Massachusetts.
Recently issued recall letters:
OEC 9900 Series
OEC 9800 Series
OEC 9600 Series
OEC 8800 Series
OEC 7700 Series
OEC 7600 Series
InstaTrak 3500 Series
Accessories
Previously issued recall letters:
OEC 9900 Series
- Important - Electronic Product Radiation Warning Letter, OEC 9800 and 9900 Elite dated October 17, 2007.
- Important Electronic Product Radiation Warning Letter dated July 11,2007.
- Important Electronic Product Radiation Warning dated June 12, 2007.
- Urgent Recall Notice dated April 13, 2007. Update to Recall Notice dated November 8, 2006.
- Urgent Recall Notice dated April 2, 2007. Fluorotrack Spinal Application on the OEC® 9900 Elite Nav.
- Important Electronic Product Radiation Warning dated April 2, 2007. OEC 9900® Elite, OEC® 9800, OEC® 8800, OEC® 6800, OEC® 2800.
- Urgent Recall Notice dated March 21, 2007. Four (4) pedal footswitch potential safety issues.
- Urgent Recall Notice dated February 28, 2007 X-ray tube &/or collimator replaced for OEC 9800, FluoroTrak 9800 Plus, 9800 Plus, 9800MD Motor C-arm, 9900 Elite, 9900MD Motor C-arm, 9900 EliteNAV, 8800.
- Recall Notice 9900 series dated November 8, 2006.
OEC 9800 Series
- Important - Electronic Product Radiation Warning Letter, OEC 9800 and 9900 Elite dated October 17, 2007.
- Important Electronic Product Radiation Warning Letter dated July 11,2007.
- Important Electronic Product Radiation Warning dated June 12, 2007.
- Urgent Recall Notice dated April 13, 2007. Update to Recall Notice dated November 8, 2006.
- Important Electronic Product Radiation Warning dated April 2, 2007. OEC 9900® Elite, OEC® 9800, OEC® 8800, OEC® 6800, OEC® 2800.
- Urgent Recall Notice dated March 21, 2007. Four (4) pedal footswitch potential safety issues.
- Urgent Recall Notice dated February 28, 2007 X-ray tube &/or collimator replaced for OEC 9800, FluoroTrak 9800 Plus, 9800 Plus, 9800MD Motor C-arm, 9900 Elite, 9900MD Motor C-arm, 9900 EliteNAV, 8800.
- Urgent Recall Notice dated February 21, 2007. Service-installed hard disk drives for OEC UroView 2800, OEC 9800 Plus Digital, OEC MiniView 6800, OEC FlexiView 8800, Mobile C-Arm.
- Urgent Recall Notice dated February 9, 2007. Camera cover on the Image Intensifier replaced during a service call.
- Recall Notice FlexiView 8800 Mobile C-Arm, OEC® UroView 2800, OEC® 9800, OEC®FluoroTrak 9800 Plus, OEC® 9800 Plus, OEC® 9800MD Motorized C-arm System, and OEC® Miniview 6800.
OEC 8800
- Important Electronic Product Radiation Warning dated June 12, 2007.
- Important Electronic Product Radiation Warning dated April 2, 2007. OEC 9900® Elite, OEC® 9800, OEC® 8800, OEC® 6800, OEC® 2800.
- Urgent Recall Notice dated April 13, 2007. Update to Recall Notice dated November 8, 2006.
- Urgent Recall Notice dated February 28, 2007 X-ray tube &/or collimator replaced for OEC 9800, FluoroTrak 9800 Plus, 9800 Plus, 9800MD Motor C-arm, 9900 Elite, 9900MD Motor C-arm, 9900 EliteNAV, 8800.
- Urgent Recall Notice dated February 21, 2007. Service-installed hard disk drives for OEC UroView 2800, OEC 9800 Plus Digital, OEC MiniView 6800, OEC FlexiView 8800, Mobile C-Arm.
- Recall Notice FlexiView 8800 Mobile C-Arm, OEC® UroView 2800, OEC® 9800, OEC®FluoroTrak 9800 Plus, OEC® 9800 Plus, OEC® 9800MD Motorized C-arm System, and OEC® Miniview 6800.
OEC 6800
- Important Electronic Product Radiation Warning letter, OEC MiniView 6800 dated May 24, 2007.
- Important Electronic Product Radiation Warning dated June 12, 2007.
- Important Electronic Product Radiation Warning dated April 2, 2007. OEC 9900® Elite, OEC® 9800, OEC® 8800, OEC® 6800, OEC® 2800.
- Urgent Recall Notice dated February 21, 2007. Service-installed hard disk drives for OEC UroView 2800, OEC 9800 Plus Digital, OEC MiniView 6800, OEC FlexiView 8800, Mobile C-Arm.
- Recall Notice FlexiView 8800 Mobile C-Arm, OEC® UroView 2800, OEC® 9800, OEC®FluoroTrak 9800 Plus, OEC® 9800 Plus, OEC® 9800MD Motorized C-arm System, and OEC® Miniview 6800.
Uroview
- Important Electronic Product Radiation Warning dated June 12, 2007.
- Important Electronic Product Radiation Warning dated April 2, 2007. OEC 9900® Elite, OEC® 9800, OEC® 8800, OEC® 6800, OEC® 2800.
- Urgent Recall Notice dated February 21, 2007. Service-installed hard disk drives for OEC UroView 2800, OEC 9800 Plus Digital, OEC MiniView 6800, OEC FlexiView 8800, Mobile C-Arm.
- Recall Notice OEC® UroView 2800 and OEC® UroView 2800 with and/or OEC® UroView 2800 with Dual Monitor Options dated January 12, 2007.
ENTrak
InstaTrak 3500
- Important - Urgent Recall Notice, InstaTrak 3500 Plus, dated October 11, 2007.
- Important - Urgent Recall Notice, InstaTrak 3500, dated September 28, 2007.
- Important - Urgent Recall Notice, OEC InstaTrak 3500 dated September 28, 2007.
- Urgent Recall Notice dated May 18, 2007. Sterile packed single use disposable accessories to the InstaTrak 3500 Plus.
- Urgent Recall Notice dated March 22, 2007. Insta Trak 3500 Spinal Application.
- Urgent Removal Notice dated January 24, 2007. Axcess Cranial Screw (Accessory used with GE OEC InstaTrak™ 3500 Plus/ ENTrak™ Plus System).
- Recall Notice GE OEC InstaTrak™3500 Plus System dated October 11, 2006.
Accessories
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More information is available:
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A letter to our valued customers from Pete McCabe dated April 18, 2008.
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Vertical Life Column Power Supply Replacement letter dated April 16, 2008. Letter delivered to 8800, 9800 and 9900 owners who have had their power supply replaced.
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Letter from Pete McCabe dated March 5, 2008. Audit has been completed.
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Letter from Pete McCabe dated December 28, 2007. Update on Surgery’s progress.
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Letter dated November 9, 2007 from Pete McCabe.
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Letter dated July 30, 2007 to our Valued Customers from Pete McCabe.
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Letter to our valued customers dated May 21, 2007.
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GE Healthcare Press Release
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A letter to our Customers dated January 15, 2007.
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A Letter to our Customers dated March 21, 2007.
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If you have questions please email communicationssurgery@ge.com.
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Please direct all inquires to our service center at 1-800-874-7378, option 8.
Media inquiries, please contact:
GE Healthcare
Corey Miller
T 262-721-2421
C 414-469-5499
or via email.
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