OEC 9800 Plus

• • Ongoing Z-2341-2025 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-0706-2025 FDA Class II ·initiated 21 Nov 2024 ·on shared 510(k) K132027

  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-2276-2023 FDA Class II ·initiated 15 May 2023
  • Ongoing Z-2279-2023 FDA Class II ·initiated 15 May 2023 ·on shared 510(k) K132027

  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) K132027

  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-1059-2017 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-0973-2017 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.

• • Terminated Z-0195-2015 FDA Class II ·initiated 3 Oct 2014

  GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.

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

510(k) Number

K132027 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• OEC Elite Open recall

  Class II

  FDA 510(k) K171565 Active Cleared 10 Aug 2017

• Oec 3D Open recall

  Class II

  FDA 510(k) K203346 Active Cleared 5 Mar 2021

• Oec Olympus Mobile Fluoroscopy System with Integrated Navigation

  Class II

  FDA 510(k) K041931 Active Cleared 26 Aug 2004

• GE Oec Everview 7500

  Class II

  FDA 510(k) K051490 Active Cleared 7 Jul 2005

• Oec Fluorotrak 9800 Plus

  Class II

  FDA 510(k) K022069 Active Cleared 17 Sep 2002

• Oec 9800 Plus Digital Mobile Imaging System Open recall

  Class II

  FDA 510(k) K021049 Active Cleared 17 Apr 2002

See all devices from GE Oec Medical Systems, Inc →

• What is the OEC 9800 Plus used for?

  The OEC 9800 Plus is an interventional fluoroscopic X-ray system designed for real-time imaging during procedures requiring precise X-ray guidance. Its C-arm configuration and high-resolution 1k x 1k detector make it suitable for interventional radiology, orthopedic surgeries, and trauma care in dynamic clinical environments like operating rooms or emergency departments.

• Is the OEC 9800 Plus supplied sterile?

  No, the OEC 9800 Plus is not sterile upon delivery. It is intended as a reusable medical device and must be cleaned and maintained according to the manufacturer’s guidelines before and after each use to ensure proper functionality and infection control.

• How is the OEC 9800 Plus classified under FDA regulations?

  The OEC 9800 Plus is classified as a Class II medical device under FDA regulations (21 CFR 892.1650). This classification reflects its moderate risk level, requiring special controls to ensure safety and effectiveness. The device holds an FDA 510(k) clearance (K132027) for special review in radiology, confirming it meets regulatory standards for interventional fluoroscopic imaging.

• What types of procedures can the OEC 9800 Plus support?

  The OEC 9800 Plus is versatile for procedures requiring real-time X-ray visualization, including interventional radiology (e.g., vascular interventions), orthopedic surgeries (e.g., fracture fixation), and trauma care (e.g., emergency stabilization). Its C-arm design allows flexible positioning around the patient, accommodating a wide range of clinical scenarios.

• Does the OEC 9800 Plus have any MRI compatibility information?

  The manufacturer does not specify MRI safety information for the OEC 9800 Plus. If MRI compatibility is required, users should consult the device’s documentation or manufacturer guidelines to ensure safe co-use in environments with MRI systems, as metallic components or imaging modalities may pose risks.