GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
This recall has been terminated (originally issued October 3, 2006).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- May 31, 2006
- Posted
- October 3, 2006
- Terminated
- July 27, 2011
- Recall Number
- Z-0001-2007
- Quantity
- 143 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.
Distribution
Nationwide, including one VA facility in PA. No military distribution. Foreign distribution to Canada, China, Italy, Japan, Spain.
Lot / Code Info
ALL LOT NUMBERS -GE Part number 1006385 or 1006385-NAV
Root Cause
Process control
Action Taken
Consignees were notified by letter on 05/31/2006
More recalls by Ge Oec Medical Systems, Inc
OEC 3D REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopi...
Dec 18, 2024
OEC 9800 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed...
Dec 18, 2024
OEC 9900 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoro...
Dec 18, 2024
OEC Elite REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is i...
Dec 18, 2024
OEC 9800 Systems with 9-inch Image Intensifier
Jul 31, 2023