Oec 9800 Plus Digital Mobile Imaging System

• • 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) K021049

  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-2279-2023 FDA Class II ·initiated 15 May 2023 ·on shared 510(k) K021049
  • Ongoing Z-2276-2023 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.

• • Terminated Z-2629-2016 FDA Class II ·initiated 22 Jul 2016

  A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.

• • 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.

• • Terminated Z-2241-2012 FDA Class II ·initiated 26 Apr 2010 ·on shared 510(k) K021049

  GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation.

• • Terminated Z-2240-2012 FDA Class II ·initiated 6 Nov 2009 ·on shared 510(k) K021049

  GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing unanticipated system shut downs, no boots, data loss or data mix, or unexpected hard drive corruption.

• • Terminated Z-2262-2012 FDA Class II ·initiated 10 Oct 2008 ·on shared 510(k) K021049

  GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.

• • Terminated Z-1730-2009 FDA Unclassified (pre-2012) ·initiated 29 Aug 2008 ·on shared 510(k) K021049

  GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have sterile seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state.

• 4 recalls, same reason

  • Terminated Z-1708-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K021049
  • Terminated Z-1707-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K021049
  • Terminated Z-1706-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K021049
  • Terminated Z-1709-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K021049

  GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.

• • Terminated Z-1705-2008 FDA Unclassified (pre-2012) ·initiated 15 Apr 2008 ·on shared 510(k) K021049

  Use of existing four-pedal footswitch on a different machine may cause various operational errors.

• • Terminated Z-2038-2012 FDA Class I ·initiated 22 Feb 2008 ·on shared 510(k) K021049

  Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure.

• • Terminated Z-2026-2012 FDA Class II ·initiated 19 Nov 2007 ·on shared 510(k) K021049

  Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.

• • Terminated Z-2125-2012 FDA Class II ·initiated 27 Mar 2007 ·on shared 510(k) K021049

  Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

• 4 recalls, same reason

  • Terminated Z-0680-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K021049
  • Terminated Z-0681-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K021049
  • Terminated Z-0677-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K021049
  • Terminated Z-0682-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K021049

  During routine service, primary and/or secondary collimators may not have been properly reinstalled.

• 4 recalls, same reason

  • Terminated Z-0558-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007 ·on shared 510(k) K021049
  • Terminated Z-0556-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007 ·on shared 510(k) K021049
  • Terminated Z-0557-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007 ·on shared 510(k) K021049
  • Terminated Z-0559-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007 ·on shared 510(k) K021049

  During routine service, a cover may have been installed without the required proper lead shielding.

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

510(k) Number

K021049 ↗

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 Olympus Fluoroscopic Imaging System

  Class II

  FDA 510(k) K041932 Active Cleared 18 Aug 2004

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