Z-0004-2010

GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy

Name: Z-0004-2010 GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy
Creator: Ge Healthcare
Published: 2009-08-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-08-12 / Terminated / root cause: software

FDA source

Ge Healthcare began a recall of GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy on 2009-08-12. The reason FDA records is "A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0004-2010
Status: Terminated
Initiated: 2009-08-12
Posted: 2010-01-20
Terminated: 2012-04-23
Recalling firm: GE Healthcare
Product: GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: An Important Electronic Product Radiation Warning letter will be sent to customers identifying the issues, interim solution, and permanent solution. Questions or concerns are to be directed to the GEHC OEC service team at 1-800-874-7378.
Quantity in commerce: 1411 units total
Distribution: Nationwide and Canadian Distribution
Product codes and lots: All associated serial numbers

Product code JAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)