CLASS II Device recall · Reported 19 Oct 2016 · FDA Enforcement Report

OEC Brivo 785 Essential recalled by GE OEC Medical Systems

GE OEC Medical Systems is recalling OEC Brivo 785 Essential, distributed nationwide in the US. The recall was initiated on 23 Sep 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGE Brivo OEC715: Serial Numbers B2S15158 to B2S15164; B2S15166 to B2S15171; B2S15173 to B2S15195; B2S15197; B2S15200; B2S15202; B2S16046; B2S16050; B2S16051 GE Brivo OEC785: Serial Numbers B3S15236; B3S15241; B3S15242; B3S15246; B3S15248; B3S15250; B3S15253 to B3S15257; B3S15259 to B3S15338; B3S15353; B3S15357 to B3S15359; B3S16152 GE Brivo OEC865: Serial Numbers B4S15063 to B4S15070; B4S15072; B4S15073; B4S15075; B4S16029

Quantity recalled148 total

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-0071-2017
FDA event ID: 75330
Recalling firm: GE OEC Medical Systems, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 23 Sep 2016
FDA classified: 11 Oct 2016
Reported: 19 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

23 Sep 2016	Recall initiated by company
11 Oct 2016	Classified by FDA	+18 days
19 Oct 2016	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

GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command.

Product as listed by the FDA

OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections or biopsy. The OEC Brivo is not indicated for interventional use.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees.

Nationwide Alabama Arizona California Florida Kansas Mississippi New Jersey Nevada New York Pennsylvania Texas Utah West Virginia

Questions about this recall

Is OEC Brivo 785 Essential recalled?

Yes. GE OEC Medical Systems recalled OEC Brivo 785 Essential on 23 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0071-2017.

Why was it recalled?

Which lots are affected?

GE Brivo OEC715: Serial Numbers B2S15158 to B2S15164; B2S15166 to B2S15171; B2S15173 to B2S15195; B2S15197; B2S15200; B2S15202; B2S16046; B2S16050; B2S16051 GE Brivo OEC785: Serial Numbers B3S15236; B3S15241; B3S15242; B3S15246; B3S15248; B3S15250; B3S15253 to B3S15257; B3S15259 to B3S15338; B3S15353; B3S15357 to B3S15359; B3S16152 GE Brivo OEC865: Serial Numbers B4S15063 to B4S15070; B4S15072; B4S15073; B4S15075; B4S16029

Where was it sold?

Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees.

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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