Mini 6800 Digital Mobile C-Arm

• • Terminated Z-0974-2017 FDA Class II ·initiated 19 Dec 2016

  GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

• • Terminated Z-0193-2015 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-0851-2007 FDA Unclassified (pre-2012) ·initiated 12 Jun 2007 ·on shared 510(k) K992506

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

• • Terminated Z-0928-2007 FDA Unclassified (pre-2012) ·initiated 24 May 2007 ·on shared 510(k) K992506

  X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures

• • Terminated Z-2126-2012 FDA Class II ·initiated 27 Mar 2007 ·on shared 510(k) K992506

  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

• • Terminated Z-2040-2012 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 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in "film mo

• • Terminated Z-0704-06 FDA Unclassified (pre-2012) ·initiated 28 Mar 2006 ·on shared 510(k) K992506

  Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.

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

510(k) Number

K992506 ↗

FDA Product Code

OXO

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Series 7600 Mobile Digital C-Arm

  Class II

  FDA 510(k) K970063 Active Cleared 11 Mar 1997

• Series 6600 Digital Mobile C-Arm

  Class II

  FDA 510(k) K951765 Active Cleared 11 May 1995

• Uroview Model 2600

  Class II

  FDA 510(k) K940295 Active Cleared 22 Aug 1994

• Compact 7600

  Class II

  FDA 510(k) K950781 Active Cleared 5 Jun 1995

• Series 9600 Mobile Digital Imaging System

  Class II

  FDA 510(k) K963952 Active Cleared 23 Dec 1996

• Uroview 2800

  Class II

  FDA 510(k) K993687 Active Cleared 21 Dec 1999

See all devices from Ge Dec Medical Systems →