Z-0975-2017Class II

The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the...

Name: Z-0975-2017 The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the...
Creator: GE OEC Medical Systems, Inc
Published: 2016-12-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2016-12-19 / Terminated

FDA source

GE OEC Medical Systems, Inc began a recall of The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and... on 2016-12-19. FDA classified it as Class II and gives the reason as "GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0975-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-19
Posted: 2017-01-09
Terminated: 2017-08-22
Recalling firm: GE Healthcare
Product: The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Reason for recall: GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
FDA root cause: Use error
Action: GE Healthcare sent an Urgent Medical Device Correction letter dated December 19, 2016, to all affected consignees. GE informed consignees that GE will correct all affected products. If consignnes have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative. For questions regarding this recall call 801-536-4952.
Distribution: Worldwide Distribution - US including U.S. States: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PUERTO RICO, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada, Mexico, and Costa Rica
Product codes and lots: Manufactured between 1/1/16 to 11/1/16

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0975-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0973-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09
Z-0974-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09
Z-0975-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

Product code OXO

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)