Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime

510(k) K123603

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK123603	Date17 May 2013Cleared	StatusActive

5 recalls · FDA

- Terminated Z-0071-2017 FDA Class II initiated 23 Sep 2016
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.
2 recalls, same reason
- Terminated Z-0840-2015 FDA Class II initiated 15 Sep 2014
- Terminated Z-0841-2015 FDA Class II initiated 15 Sep 2014
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).
- Terminated Z-1638-2015 FDA Class II initiated 22 May 2014
Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products.
- Terminated Z-0066-2014 FDA Class II initiated 18 Sep 2013
GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality.

1 jurisdiction

United States — FDA 510(k) Active

510(k)