Z-2025-2012Class II

OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate...

Name: Z-2025-2012 OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate...
Creator: GE OEC Medical Systems, Inc
Published: 2007-11-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-11-19 / Terminated / root cause: design

FDA source

GE OEC Medical Systems, Inc began a recall of OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous... on 2007-11-19. FDA classified it as Class II and gives the reason as "Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC...". 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-2025-2012
Classification: Class II
Status: Terminated
Initiated: 2007-11-19
Posted: 2012-07-18
Terminated: 2013-01-28
Recalling firm: GE Healthcare
Product: OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
Root cause tag: design
FDA root cause: Device Design
Action: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE Healthcare sent an"URGENT RECALL NOTICE" dated February 22, 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 800-874-7378 for questions concerning this recall.
Quantity in commerce: 726 units
Distribution: Worldwide Distribution.
Product codes and lots: Part numbers: 00-887200-01; 00-887200-03; 00-887201-01; 00-887201-03; 00-887202-01; 00-887202-03; 00-887204-03; 00-887207-03; 00-887206-03. Along with all associated serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2025-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2025-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-18
Z-2026-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-18
Z-2027-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-18

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)