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Oec 9900 Elite

by Ge Healthcare Surgery GE Oec Medical Systems, Inc. 2 variants

510(k) K120613

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK120613 Date6 Apr 2012ClearedStatusActive

Recalls

7 recalls · 5 ongoing · FDA

    • Ongoing Z-2342-2025 FDA Class II initiated 2 Jul 2025 on shared 510(k) K120613

    GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.

    • Ongoing Z-0705-2025 FDA Class II initiated 21 Nov 2024

    Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

  • 2 recalls, same reason

    • Ongoing Z-2277-2023 FDA Class II initiated 15 May 2023
    • Ongoing Z-2279-2023 FDA Class II initiated 15 May 2023

    Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

    • Ongoing Z-2872-2020 FDA Class II initiated 8 May 2020 on shared 510(k) K120613

    GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live update screen from AKR / CAK to DAP. All systems sold to customers in the US that leave GEHC Surgery (the place of manufacture) are configured to display AKR / CAK when they leave the factory. An FSE changing the dose display, per the customer request, to display DAP instead does not comply to 21CFR 1020.32(k), which requires fluoroscopic equipment manufactured on or after June 10, 2006 to display continuous updates of AKR and CAK values.

    • Terminated Z-1060-2017 FDA Class II initiated 27 Dec 2016 on shared 510(k) K120613

    GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.

    • Terminated Z-0975-2017 FDA Class II initiated 19 Dec 2016

    GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OXO
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Ge Healthcare Surgery GE Oec Medical Systems, Inc.