Skip to content

OEC Brivo Prime

by GE Hualun Medical Systems Co., Ltd

OEC Brivo Prime is a Class II device made by GE Hualun Medical Systems Co., Ltd, cleared under FDA 510(k) K123603 on 17 May 2013 and listed in FDA GUDID since 27 May 2016 (UDI-DI 00840682115360), active as of 23 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

510(k) K123603

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682115360 UDI-DI Date27 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123603 Date17 May 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123603 decided 17 May 2013 Active
  • FDA GUDID UDI-DI 00840682115360 listed 27 May 2016 Listed

Recalls

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.

Timeline

7 dated events

  1. Cleared FDA 510(k) K123603
  2. Recall initiated FDA recalls Z-0066-2014
  3. Recall initiated FDA recalls Z-1638-2015
  4. Recall initiated FDA recalls Z-0840-2015
  5. Recall initiated FDA recalls Z-0841-2015
  6. Listed FDA GUDID 00840682115360
  7. Recall initiated FDA recalls Z-0071-2017

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Oec
Generic name
Mobile general-purpose fluoroscopic x-ray system, digital
Model / reference
Brivo Prime
Primary DI / UDI-DI
00840682115360
510(k) Number
FDA product code
JAA, OXO
GMDN term
Mobile general-purpose fluoroscopic x-ray system, digital
Device class
Class II
Regulation number
892.1650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Mobile general-purpose fluoroscopic x-ray system, digital

Cleared under the same submission (K123603)

Similar devices in this category

Other devices filed under Mobile general-purpose fluoroscopic x-ray system, digital.

Other devices from GE Hualun Medical Systems Co., Ltd

See all devices from GE Hualun Medical Systems Co., Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)