Z-0194-2015Class II

FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to...

Name: Z-0194-2015 FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to...
Creator: GE OEC Medical Systems, Inc
Published: 2014-10-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-10-03 / Terminated / root cause: design

FDA source

GE OEC Medical Systems, Inc began a recall of FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of... on 2014-10-03. FDA classified it as Class II and gives the reason as "GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems". 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-0194-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-03
Posted: 2014-11-07
Terminated: 2015-03-23
Recalling firm: GE Healthcare
Product: FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Reason for recall: GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
Root cause tag: design
FDA root cause: Component design/selection
Action: On October 3. 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to customers to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter was sent to 3 titles at each facility affected: 1.1 Facility Administrator. 2.1 Director/Manager of Radiology and Radiologists, 3.) Radiology Department. Firm will track all service requests for the field action to completion. These service requests will document the inspection and component replacement (if applicable) on the affected units. Exceptions to completion of the service request will be recorded. Records of field action completion will be retained per our processes and procedures. No product is being returned.
Quantity in commerce: 5
Distribution: Worldwide Distribution.
Product codes and lots: Serial No: 3120PU3, 4851PU2, 5640PU8, 6052PU5, FIB0064

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0194-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0192-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07
Z-0193-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07
Z-0194-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07
Z-0195-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07

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