OEC 9900 ELITE

• • Ongoing Z-2342-2025 FDA Class II ·initiated 2 Jul 2025

  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 ·on shared 510(k) K122234

  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.

• • Ongoing Z-2277-2023 FDA Class II ·initiated 15 May 2023 ·on shared 510(k) K122234

  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) K122234

  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

  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 ·on shared 510(k) K122234

  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.

510(k) Number

K122234 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Oec 9900 Elite Open recall

  Class II

  FDA 510(k) K120613 Active Cleared 6 Apr 2012

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

  Class II

  FDA 510(k) K123603 Active Cleared 17 May 2013

• What is the OEC 9900 ELITE used for?

  The OEC 9900 ELITE is a mobile C-arm device designed for surgical imaging and interventional procedures. It is intended for use in clinical, surgical, and vascular settings to provide real-time X-ray imaging during procedures.

• How is the OEC 9900 ELITE supplied?

  The device is supplied as a complete system, including all necessary components for interventional fluoroscopic imaging. It is not reusable and is intended for single-use procedures in clinical environments.

• What is the regulatory status of the OEC 9900 ELITE?

  The OEC 9900 ELITE has received FDA 510(k) clearance with K number K122234. It is classified as a Class 2 device under the product code OWB and regulation number 892.1650, deemed substantially equivalent to other devices on the market.

• What are the specifications of the OEC 9900 ELITE?

  The OEC 9900 ELITE is an Interventional Fluoroscopic X-Ray System with mobile C-arm functionality. It was manufactured by GE Healthcare Surgery GE Oec Medical Systems, Inc. and received FDA clearance on August 16, 2012.