Z-2065-2012Class I

OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system

Name: Z-2065-2012 OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system
Creator: GE OEC Medical Systems, Inc
Published: 2006-11-20
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-11-20 / Terminated / root cause: design

FDA source

GE OEC Medical Systems, Inc began a recall of OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film... on 2006-11-20. FDA classified it as Class I 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. The OEC 8800 Flexview was recalled in November 2006 due to...". 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-2065-2012
Classification: Class I
Status: Terminated
Initiated: 2006-11-20
Posted: 2012-07-24
Terminated: 2013-05-13
Recalling firm: GE Healthcare
Product: OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
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. The OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod
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 two Urgent Recall Notice letters to the Facility Administrator and the Radiology Administrator. The letters identified the affected product, problem and actions to be taken. The letters advised consignees that GE Healthcare is actively working on solutions that will permanently resolve each of the issues. For questions or concerns contact GE Healthcare service team at 800-874-7378 option 8.
Quantity in commerce: 1257 units (472 domestic systems)
Distribution: Worldwide Distribution - US Nationwide
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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2065-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2065-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-24

Product code OXO

K003837Class IIFlexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems / cleared 2001-03-12

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)