Z-1301-06

GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc

Name: Z-1301-06 GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc
Creator: GE OEC Medical Systems, Inc
Published: 2006-08-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-08-16 / Terminated

FDA source

GE OEC Medical Systems, Inc began a recall of GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc on 2006-08-16. The reason FDA records is "X-ray systems could provide output which exceeds the 20 R/minute limit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1301-06
Status: Terminated
Initiated: 2006-08-16
Posted: 2006-09-30
Terminated: 2011-07-27
Recalling firm: GE Healthcare
Product: GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: X-ray systems could provide output which exceeds the 20 R/minute limit.
FDA root cause: Other
Action: Consignees were notified by certified letter on 08/14-15/2006.
Quantity in commerce: 202 units (US), 26 units (Foreign)
Distribution: Worldwide
Product codes and lots: All units.

Product code JAA

K041931Class IIOec Olympus Mobile Fluoroscopy System with Integrated NavigationGe Oec Medical Systems, Inc. / cleared 2004-08-26

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)