Philips Integris Allura Flat Detector Release 1.2

• • Ongoing Z-1077-2025 FDA Class II ·initiated 13 Jan 2025 ·on shared 510(k) K031333

  Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

• • Ongoing Z-1151-2024 FDA Class II ·initiated 2 Jan 2024 ·on shared 510(k) K031333

  Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

• 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.

• 8 recalls, same reason

  • Terminated Z-3218-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3214-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3220-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3216-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3217-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3219-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3213-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3215-2018 FDA Class II ·initiated 16 Jul 2018

  There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.

• 2 recalls, same reason

  • Terminated Z-1822-2017 FDA Class II ·initiated 22 Mar 2017 ·on shared 510(k) K031333
  • Terminated Z-1820-2017 FDA Class II ·initiated 22 Mar 2017 ·on shared 510(k) K031333

  Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

• • 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-1462-2012 FDA Not yet classified ·initiated 2 Apr 2012

  The monitor Ceiling suspension may fail, which may cause the monitor to drop.

• • Terminated Z-2976-2011 FDA Unclassified (pre-2012) ·initiated 8 Jul 2011

  System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period.

• • 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.

• • 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.

• • Terminated Z-2471-2010 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-0370-2007 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.

• • Terminated Z-0165-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006

  Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.

• • Terminated Z-0581-06 FDA Unclassified (pre-2012) ·initiated 6 Feb 2006

  Potential lock-up of system requiring reboot of system.

• 2 recalls, same reason

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

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

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

510(k) Number

K031333 ↗

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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• Ep Navigator R3

  Class II

  FDA 510(k) K101311 Active Cleared 30 Sep 2010

• Orthoralix Sd/Orthoralix Sd Ceph

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• Doppler Option for Platinum

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• Philips Bucky Diagnost Family

  Class II

  FDA 510(k) K945278 Active Cleared 14 Dec 1994

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