CLASS II Device recall · Reported 22 Mar 2017 · FDA Enforcement Report

OEC FlexiView 8800, Digital Mobile Imaging System recalled

GE OEC Medical Systems is recalling OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems, distributed in California. The recall was initiated on 21 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesOEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.

Quantity recalled1

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1469-2017
FDA event ID: 76568
Recalling firm: GE OEC Medical Systems, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 21 Feb 2017
FDA classified: 14 Mar 2017
Reported: 22 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

21 Feb 2017	Recall initiated by company
14 Mar 2017	Classified by FDA	+21 days
22 Mar 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

One consignee in CA.

California

Questions about this recall

Is OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems recalled?

Yes. GE OEC Medical Systems recalled OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems on 21 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1469-2017.

Why was it recalled?

OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.

Which lots are affected?

OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.

Where was it sold?

One consignee in CA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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