Z-1469-2017Class II

OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems

Name: Z-1469-2017 OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
Creator: GE OEC Medical Systems, Inc
Published: 2017-02-21
License: https://open.fda.gov/license/

GE Healthcare / initiated 2017-02-21 / Terminated / root cause: manufacturing process

FDA source

GE OEC Medical Systems, Inc began a recall of OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems on 2017-02-21. FDA classified it as Class II and gives the reason as "OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1469-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-21
Posted: 2017-02-27
Terminated: 2017-04-24
Recalling firm: GE Healthcare
Product: OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Reason for recall: OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 21, 2017, an Urgent Medical Device Correction letter was sent to one consignee with an affected unit; a field service representative hand delivered the customer communication.
Quantity in commerce: 1
Distribution: One consignee in CA.
Product codes and lots: OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1469-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1469-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-14

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)