Z-1706-2008

OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and...

Name: Z-1706-2008 OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and...
Creator: OEC Medical Systems, Inc
Published: 2008-04-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-04-15 / Terminated / root cause: design

FDA source

OEC Medical Systems, Inc began a recall of OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare... on 2008-04-15. The reason FDA records is "Use of existing four-pedal footswitch on a different machine may cause various operational errors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1706-2008
Status: Terminated
Initiated: 2008-04-15
Posted: 2008-09-01
Terminated: 2011-12-21
Recalling firm: GE Healthcare
Product: OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Use of existing four-pedal footswitch on a different machine may cause various operational errors.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified by letter on 03/21/2007 and advised that GE would be replacing the 4-pedal switches at some time in the future. Replacement began on 04/15/2008. Contact GE Healthcare at 1-800-874-7378 for assistance.
Quantity in commerce: 25 units
Distribution: Nationwide, including one VA facility in FL. No military or foreign distribution.
Product codes and lots: Serial numbers: E2-0034, E2-0088, E2-0109, E2-0258, E2-0270, E2-7019-MH, E2-7020-MH, E2-7034-CMH, E2-7037-MH, E2-7043-MH, E9-0029, E9-0047, E9-0169, E9-0171, E9-0172, E9-0173, E9-0177, ES-0113, ES-7015-MH.

Product code JAA

K041932Class IIOec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. / cleared 2004-08-18

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)