Z-0841-2015Class II

GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal...

Name: Z-0841-2015 GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal...
Creator: GE OEC Medical Systems, Inc
Published: 2014-09-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-09-15 / Terminated / root cause: labeling and UDI

FDA source

GE OEC Medical Systems, Inc began a recall of GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize on 2014-09-15. FDA classified it as Class II and gives the reason as "mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0841-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-15
Posted: 2015-01-13
Terminated: 2015-05-20
Recalling firm: GE Healthcare
Product: GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Reason for recall: mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will, without charge, perform a mA calibration on all affected systems in the USA to bring the product back into compliance. The details of which will be included in a subsequent communication to customers or through a GE Healthcare field engineer site visit. Should customers have any questions or concerns regarding these corrections, please do not hesitate to contact the service team for further information at 800-874-7378 option 8.
Quantity in commerce: 61 units installed in US
Distribution: Worldwide Distribution
Product codes and lots: GE OEC Brivo 865 Plus Serial Numbers: B4S13011 B4S13012 B4S13016 B4S13018 B4S13020 B4S13029 B4S13031 B4S13035 B4S13038 B4S13043 B4S13054 B4S13056 B4S13059- B4S13061 B4S14002- B4S14004 B4S14007 B4S14015 B4S14016 B4S14022 B4S14022 B4S1403 3 B4S1403 4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0841-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0840-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-12
Z-0841-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-12

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)