Oec 9800 E/Cv+ Digital Mobile Imaging System

• • Terminated Z-2241-2012 FDA Class II ·initiated 26 Apr 2010 ·on shared 510(k) K024012

  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

  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) K024012

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

• 2 recalls, same reason

  • Terminated Z-1885-2008 FDA Unclassified (pre-2012) ·initiated 12 Aug 2008
  • Terminated Z-1884-2008 FDA Unclassified (pre-2012) ·initiated 12 Aug 2008

  Beam limitation may be non-compliant on some X-ray units.

• • Terminated Z-1705-2008 FDA Unclassified (pre-2012) ·initiated 15 Apr 2008

  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

  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

  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-0990-2007 FDA Unclassified (pre-2012) ·initiated 6 Jul 2007

  The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.

• • Terminated Z-0849-2007 FDA Unclassified (pre-2012) ·initiated 12 Jun 2007

  X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

• 4 recalls, same reason

  • Terminated Z-0677-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007
  • Terminated Z-0681-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007
  • Terminated Z-0680-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007
  • Terminated Z-0682-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007

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

• 4 recalls, same reason

  • Terminated Z-0556-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007
  • Terminated Z-0558-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007
  • Terminated Z-0559-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007
  • Terminated Z-0557-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007

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

• • Terminated Z-1302-06 FDA Unclassified (pre-2012) ·initiated 16 Aug 2006

  X-ray systems could provide output which exceeds the 20 R/minute limit.

• • Terminated Z-0001-2007 FDA Unclassified (pre-2012) ·initiated 31 May 2006

  Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.

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

510(k) Number

K024012 ↗

FDA Product Code

JAA

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 →