Z-0071-2017Class II

OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance

Name: Z-0071-2017 OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance
Creator: GE OEC Medical Systems, Inc
Published: 2016-09-23
License: https://open.fda.gov/license/

GE Healthcare / initiated 2016-09-23 / Terminated / root cause: manufacturing process

FDA source

GE OEC Medical Systems, Inc began a recall of 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... on 2016-09-23. FDA classified it as Class II and gives the reason as "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...". 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-0071-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-23
Posted: 2016-10-11
Terminated: 2017-04-24
Recalling firm: GE Healthcare
Product: 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.
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: GE Healthcare sent an Urgent Medical Device Correction letter dated September 23, 2016 to customers. The letter informed customers of the affected product, safety issue, and safety instructions for immediate mitigation of the issue. GE Healthcare will correct all affected products at no cost to customers. A GE Healthcare representative will the customers to arrange for the correction. Please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 148 total
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0071-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0071-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-11

Product code OXO

K123603Class IIOec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 PrimeGe Healthcare Surgery GE Oec Medical Systems, Inc. / cleared 2013-05-17

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)