Z-0368-2008

GE Healthcare OEC 9900 mobile fluoroscopic x-ray system

Name: Z-0368-2008 GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
Creator: OEC Medical Systems, Inc
Published: 2007-12-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-12-14 / Terminated / root cause: software

FDA source

OEC Medical Systems, Inc began a recall of GE Healthcare OEC 9900 mobile fluoroscopic x-ray system on 2007-12-14. The reason FDA records is "Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default...". 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-0368-2008
Status: Terminated
Initiated: 2007-12-14
Posted: 2008-09-29
Terminated: 2012-04-13
Recalling firm: GE Healthcare
Product: GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected.
Root cause tag: software
FDA root cause: Software design
Action: GE OEC sent a letter to customers December 15, 2007, and scheduled field representative visits for corrective software solution installation.
Quantity in commerce: 710
Distribution: Worldwide distribution: USA, Finland, Netherlands, Germany, Switzerland, France, United Kingdom, Australia, Italy, Ireland, Spain, Sweden, Belgium, New Zealand, China, Singapore, Poland, Norway, and India.
Product codes and lots: All codes

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