Flexiview 8800 Digital Mobile Imaging System

• 2 recalls, same reason

  • Ongoing Z-2279-2023 FDA Class II ·initiated 15 May 2023
  • Ongoing Z-2275-2023 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-1469-2017 FDA Class II ·initiated 21 Feb 2017

  OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.

• • Terminated Z-0194-2015 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-2027-2012 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-2221-2012 FDA Class II ·initiated 19 Oct 2007 ·on shared 510(k) K003837

  X-ray units did not meet manufacturer's specification for linearity.

• • Terminated Z-0850-2007 FDA Unclassified (pre-2012) ·initiated 12 Jun 2007 ·on shared 510(k) K003837

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

• • Terminated Z-0678-2007 FDA Unclassified (pre-2012) ·initiated 1 Mar 2007 ·on shared 510(k) K003837

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

• • Terminated Z-2065-2012 FDA Class I ·initiated 20 Nov 2006

  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 OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod

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

510(k) Number

K003837 ↗

FDA Product Code

OXO

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 →