Z-0001-2007

GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems...

Name: Z-0001-2007 GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems...
Creator: GE OEC Medical Systems, Inc
Published: 2006-05-31
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-05-31 / Terminated / root cause: manufacturing process

FDA source

GE OEC Medical Systems, Inc began a recall of 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... on 2006-05-31. The reason FDA records is "Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0001-2007
Status: Terminated
Initiated: 2006-05-31
Posted: 2006-10-03
Terminated: 2011-07-27
Recalling firm: GE Healthcare
Product: 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)
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by letter on 05/31/2006
Quantity in commerce: 143 units
Distribution: Nationwide, including one VA facility in PA. No military distribution. Foreign distribution to Canada, China, Italy, Japan, Spain.
Product codes and lots: ALL LOT NUMBERS -GE Part number 1006385 or 1006385-NAV

Product code JAA

K024012Class IIOec 9800 E/cv+ Digital Mobile Imaging SystemGe Oec Medical Systems / cleared 2003-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)