Philips Integris Allura Flat Detector Release 1.0

• • Terminated Z-1654-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010 ·on shared 510(k) K022899

  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 ·on shared 510(k) K022899

  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.

• 2 recalls, same reason

  • Terminated Z-0347-2009 FDA Unclassified (pre-2012) ·initiated 10 Dec 2008 ·on shared 510(k) K022899
  • Terminated Z-0350-2009 FDA Unclassified (pre-2012) ·initiated 10 Dec 2008 ·on shared 510(k) K022899

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

• 2 recalls, same reason

  • Terminated Z-2477-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008 ·on shared 510(k) K022899
  • Terminated Z-2474-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008 ·on shared 510(k) K022899

  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.

• 2 recalls, same reason

  • Terminated Z-0368-2007 FDA Unclassified (pre-2012) ·initiated 14 Dec 2006 ·on shared 510(k) K022899
  • Terminated Z-0369-2007 FDA Unclassified (pre-2012) ·initiated 14 Dec 2006 ·on shared 510(k) K022899

  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.

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

510(k) Number

K022899 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Tomoscan Stereotaxis Simulation Software

  Class II

  FDA 510(k) K900660 Active Cleared 13 Mar 1990

• Integris 3D-Ra, Release 4.2

  Class II

  FDA 510(k) K040254 Active Cleared 19 Feb 2004

• Ep Navigator R3

  Class II

  FDA 510(k) K101311 Active Cleared 30 Sep 2010

• Orthoralix Sd/Orthoralix Sd Ceph

  Class II

  FDA 510(k) K890351 Active Cleared 15 Jun 1989

• Doppler Option for Platinum

  Class II

  FDA 510(k) K900002 Active Cleared 2 Apr 1990

• Philips Bucky Diagnost Family

  Class II

  FDA 510(k) K945278 Active Cleared 14 Dec 1994

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