Oec Olympus Fluoroscopic Imaging System

• • Terminated Z-2241-2012 FDA Class II ·initiated 26 Apr 2010 ·on shared 510(k) K041932

  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-2262-2012 FDA Class II ·initiated 10 Oct 2008 ·on shared 510(k) K041932

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

• • Terminated Z-1706-2008 FDA Unclassified (pre-2012) ·initiated 15 Apr 2008 ·on shared 510(k) K041932

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

• • Terminated Z-2025-2012 FDA Class II ·initiated 19 Nov 2007 ·on shared 510(k) K041932

  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.

• 3 recalls, same reason

  • Terminated Z-0683-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K041932
  • Terminated Z-0676-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K041932
  • Terminated Z-0679-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K041932

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

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

510(k) Number

K041932 ↗

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 →