Uroview 2800

• 2 recalls, same reason

  • Terminated Z-2629-2016 FDA Class II ·initiated 22 Jul 2016
  • Terminated Z-2628-2016 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-0192-2015 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-1730-2009 FDA Unclassified (pre-2012) ·initiated 29 Aug 2008 ·on shared 510(k) K993687

  GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have sterile seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state.

• 4 recalls, same reason

  • Terminated Z-1707-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K993687
  • Terminated Z-1706-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K993687
  • Terminated Z-1709-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K993687
  • Terminated Z-1708-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K993687

  GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.

• • Terminated Z-0852-2007 FDA Unclassified (pre-2012) ·initiated 12 Jun 2007 ·on shared 510(k) K993687

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

• • Terminated Z-2127-2012 FDA Class II ·initiated 27 Mar 2007 ·on shared 510(k) K993687

  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-0514-2007 FDA Unclassified (pre-2012) ·initiated 15 Jan 2007 ·on shared 510(k) K993687

  Uroview 2800 system with dual monitors may pose a safety risk to patients if the monitors become disconnected and fall.

• • Terminated Z-0515-2007 FDA Unclassified (pre-2012) ·initiated 15 Jan 2007 ·on shared 510(k) K993687

  Uroview 2800 system with 3 Phase Power Distribution Box (Wonder Box) option can present a shock hazard to the user if the access door to the power box is not completely closed when the unit is powered on. .

• • Terminated Z-1865-2012 FDA Class II ·initiated 20 Nov 2006 ·on shared 510(k) K993687

  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 mode" and "digital spot mode", and the system does not reboot.

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

510(k) Number

K993687 ↗

FDA Product Code

OWB

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

• Mini 6800 Digital Mobile C-Arm

  Class II

  FDA 510(k) K992506 Active Cleared 19 Aug 1999

• Series 9600 Mobile Digital Imaging System

  Class II

  FDA 510(k) K963952 Active Cleared 23 Dec 1996

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