Oec Fluorotrak 9800 Plus

• • 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) K022069

  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) K022069

  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) K022069

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

• • Terminated Z-1705-2008 FDA Unclassified (pre-2012) ·initiated 15 Apr 2008 ·on shared 510(k) K022069

  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) K022069

  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) K022069

  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.

• 4 recalls, same reason

  • Terminated Z-0677-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K022069
  • Terminated Z-0680-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K022069
  • Terminated Z-0681-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K022069
  • Terminated Z-0682-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K022069

  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) K022069
  • Terminated Z-0557-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007 ·on shared 510(k) K022069
  • Terminated Z-0556-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007 ·on shared 510(k) K022069
  • Terminated Z-0559-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007 ·on shared 510(k) K022069

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

• • Terminated Z-0709-06 FDA Unclassified (pre-2012) ·initiated 6 Feb 2006 ·on shared 510(k) K022069

  Small retaining pin may detach and fall into the surgical field during stereotactic surgery.

• • Terminated Z-0692-5 FDA Unclassified (pre-2012) ·initiated 13 Dec 2004 ·on shared 510(k) K022069

  Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.

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

510(k) Number

K022069 ↗

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 9800 Plus Digital Mobile Imaging System Open recall

  Class II

  FDA 510(k) K021049 Active Cleared 17 Apr 2002

• Oec Olympus Fluoroscopic Imaging System

  Class II

  FDA 510(k) K041932 Active Cleared 18 Aug 2004

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