Allura Xper FD20

• 13 recalls, same reason

  • Ongoing Z-1148-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1160-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1151-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1144-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1158-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1154-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1149-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1142-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1150-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1145-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1143-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1159-2025 FDA Class I ·initiated 13 Jan 2025
  • Ongoing Z-1147-2025 FDA Class I ·initiated 13 Jan 2025

  Possibility of the patient falling from the table related to the mattress used on the patient table.

• • Ongoing Z-1080-2025 FDA Class II ·initiated 13 Jan 2025

  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-1144-2024 FDA Class II ·initiated 2 Jan 2024

  Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.

• 2 recalls, same reason

  • Terminated Z-1140-2019 FDA Class II ·initiated 19 Feb 2019 ·on shared 510(k) K033737
  • Terminated Z-1141-2019 FDA Class II ·initiated 19 Feb 2019 ·on shared 510(k) K033737

  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.

• 4 recalls, same reason

  • Terminated Z-3223-2018 FDA Class II ·initiated 16 Jul 2018 ·on shared 510(k) K033737
  • Terminated Z-3221-2018 FDA Class II ·initiated 16 Jul 2018 ·on shared 510(k) K033737
  • Terminated Z-3222-2018 FDA Class II ·initiated 16 Jul 2018 ·on shared 510(k) K033737
  • Terminated Z-3224-2018 FDA Class II ·initiated 16 Jul 2018 ·on shared 510(k) K033737

  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.

• • Terminated Z-1822-2017 FDA Class II ·initiated 22 Mar 2017

  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.

• 2 recalls, same reason

  • Terminated Z-1062-2017 FDA Class II ·initiated 9 Dec 2016 ·on shared 510(k) K033737
  • Terminated Z-1061-2017 FDA Class II ·initiated 9 Dec 2016 ·on shared 510(k) K033737

  System may lock up.

• • Terminated Z-0922-2017 FDA Class II ·initiated 1 Dec 2016

  Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

• • Terminated Z-0764-2016 FDA Class II ·initiated 3 Nov 2015

  Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).

• • Terminated Z-0810-2016 FDA Class II ·initiated 6 Jul 2015 ·on shared 510(k) K033737

  The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.

• 9 recalls, same reason

  • Terminated Z-0346-2016 FDA Class II ·initiated 3 Feb 2015
  • Terminated Z-0351-2016 FDA Class II ·initiated 3 Feb 2015
  • Terminated Z-0348-2016 FDA Class II ·initiated 3 Feb 2015
  • Terminated Z-0350-2016 FDA Class II ·initiated 3 Feb 2015
  • Terminated Z-0347-2016 FDA Class II ·initiated 3 Feb 2015
  • Terminated Z-0349-2016 FDA Class II ·initiated 3 Feb 2015
  • Terminated Z-0352-2016 FDA Class II ·initiated 3 Feb 2015
  • Terminated Z-0354-2016 FDA Class II ·initiated 3 Feb 2015
  • Terminated Z-0353-2016 FDA Class II ·initiated 3 Feb 2015

  Monitor Ceiling Suspension system may fall

• • Terminated Z-1280-2016 FDA Class II ·initiated 24 Sep 2014 ·on shared 510(k) K033737

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

• 2 recalls, same reason

  • Terminated Z-0182-2015 FDA Class II ·initiated 8 Jul 2014
  • Terminated Z-0181-2015 FDA Class II ·initiated 8 Jul 2014

  Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.

• • Terminated Z-1462-2012 FDA Not yet classified ·initiated 2 Apr 2012 ·on shared 510(k) K033737

  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 ·on shared 510(k) K033737

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

• • Terminated Z-1368-2011 FDA Unclassified (pre-2012) ·initiated 4 Nov 2010 ·on shared 510(k) K033737

  Adjustment of the micro-switches in the footswitch used on the Philips cardiovascular X-ray systems was not implemented. If it is programmed for exposure, it is possible that after pressing the pedal on the footswitch it does not release itself. The patient may be exposed to X-ray longer than intended.

• • Terminated Z-2448-2010 FDA Unclassified (pre-2012) ·initiated 4 Feb 2010 ·on shared 510(k) K033737

  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 ·on shared 510(k) K033737

  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.

• 2 recalls, same reason

  • Terminated Z-0349-2009 FDA Unclassified (pre-2012) ·initiated 10 Dec 2008 ·on shared 510(k) K033737
  • Terminated Z-0348-2009 FDA Unclassified (pre-2012) ·initiated 10 Dec 2008 ·on shared 510(k) K033737

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

• 2 recalls, same reason

  • Terminated Z-2476-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008 ·on shared 510(k) K033737
  • Terminated Z-2475-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008 ·on shared 510(k) K033737

  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-0329-2008 FDA Unclassified (pre-2012) ·initiated 24 Sep 2007 ·on shared 510(k) K033737
  • Terminated Z-0330-2008 FDA Unclassified (pre-2012) ·initiated 24 Sep 2007 ·on shared 510(k) K033737

  Inaccurate anatomical measurements when using the optional SmartMask feature

• • Terminated Z-0166-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006 ·on shared 510(k) K033737

  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-0582-06 FDA Unclassified (pre-2012) ·initiated 6 Feb 2006 ·on shared 510(k) K033737

  Potential lock-up of system requiring reboot of system.

• 2 recalls, same reason

  • Terminated Z-0209-06 FDA Unclassified (pre-2012) ·initiated 12 Oct 2005 ·on shared 510(k) K033737
  • Terminated Z-0208-06 FDA Unclassified (pre-2012) ·initiated 12 Oct 2005 ·on shared 510(k) K033737

  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

K033737 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• 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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