Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems

• 2 recalls, same reason

  • Terminated Z-1140-2019 FDA Class II ·initiated 19 Feb 2019
  • Terminated Z-1141-2019 FDA Class II ·initiated 19 Feb 2019

  Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.

• • Terminated Z-1280-2016 FDA Class II ·initiated 24 Sep 2014

  Loss of key image functionality due to a bent pedal of the Footswitch.

• • Terminated Z-1655-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010

  A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown.

• • Terminated Z-2448-2010 FDA Unclassified (pre-2012) ·initiated 4 Feb 2010

  A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem could only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator are damaged and the system can not be restarted.

• • Terminated Z-2449-2010 FDA Unclassified (pre-2012) ·initiated 4 Feb 2010

  A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem can only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator are damaged and the system can not be restarted.

• 4 recalls, same reason

  • Terminated Z-0348-2009 FDA Unclassified (pre-2012) ·initiated 10 Dec 2008
  • Terminated Z-0345-2009 FDA Unclassified (pre-2012) ·initiated 10 Dec 2008
  • Terminated Z-0346-2009 FDA Unclassified (pre-2012) ·initiated 10 Dec 2008
  • Terminated Z-0344-2009 FDA Unclassified (pre-2012) ·initiated 10 Dec 2008

  Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.

• 4 recalls, same reason

  • Terminated Z-2472-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008
  • Terminated Z-2473-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008
  • Terminated Z-2471-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008
  • Terminated Z-2475-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008

  A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display.

• • Terminated Z-0367-2007 FDA Unclassified (pre-2012) ·initiated 14 Dec 2006

  Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.

• 2 recalls, same reason

  • Terminated Z-0207-06 FDA Unclassified (pre-2012) ·initiated 12 Oct 2005
  • Terminated Z-0206-06 FDA Unclassified (pre-2012) ·initiated 12 Oct 2005

  Potential for high voltage exposure involving the injector interface connector of patient support tables.

510(k) Number

K984545 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class II

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  Class II

  FDA 510(k) K945278 Active Cleared 14 Dec 1994

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