Z-0989-2007

GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT

Name: Z-0989-2007 GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT
Creator: GE OEC Medical Systems, Inc
Published: 2007-07-06
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-07-06 / Terminated

FDA source

GE OEC Medical Systems, Inc began a recall of GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT on 2007-07-06. The reason FDA records is "The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0989-2007
Status: Terminated
Initiated: 2007-07-06
Posted: 2007-07-12
Terminated: 2013-02-01
Recalling firm: GE Healthcare
Product: GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.
FDA root cause: Other
Action: Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available.
Quantity in commerce: 22 units
Distribution: Worldwide, including USA, France, Singapore, Sweden, and Switzerland.
Product codes and lots: Serial numbers: E2-0083, E2-0096, E2-0100, E2-0122, E2-0139, E2-0141, E2-0144, E2-0153, E2-7040-MH, E2-7054-MH, E2-7062-MH, E2-7070-MH, E9-0012, E9-0029, E9-0059, E9-0085, E9-0106, E9-0114, E9-0170, ES-0052, ES-0159, ES-0171.

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)