Allura Xper FD10

• 15 recalls, same reason

  • Ongoing Z-0007-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0012-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0011-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0009-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0006-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0005-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0004-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0001-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0008-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0002-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0013-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0014-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0003-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0015-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949
  • Ongoing Z-0010-2026 FDA Class II ·initiated 3 Sep 2025 ·on shared 510(k) K041949

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

• • Ongoing Z-1077-2025 FDA Class II ·initiated 13 Jan 2025 ·on shared 510(k) K041949

  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

• 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.

• 6 recalls, same reason

  • Terminated Z-3227-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3225-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3229-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3226-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3230-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-3228-2018 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.

• • Terminated Z-1822-2017 FDA Class II ·initiated 22 Mar 2017 ·on shared 510(k) K041949

  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
  • Terminated Z-1061-2017 FDA Class II ·initiated 9 Dec 2016

  System may lock up.

• • Terminated Z-0923-2017 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-0810-2016 FDA Class II ·initiated 6 Jul 2015

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

• 9 recalls, same reason

  • Terminated Z-0354-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K041949
  • Terminated Z-0352-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K041949
  • Terminated Z-0346-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K041949
  • Terminated Z-0349-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K041949
  • Terminated Z-0353-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K041949
  • Terminated Z-0347-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K041949
  • Terminated Z-0350-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K041949
  • Terminated Z-0348-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K041949
  • Terminated Z-0351-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K041949

  Monitor Ceiling Suspension system may fall

• • 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-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-1368-2011 FDA Unclassified (pre-2012) ·initiated 4 Nov 2010

  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-0124-2011 FDA Unclassified (pre-2012) ·initiated 21 Aug 2008

  Due to a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible.

• • Terminated Z-0125-2011 FDA Unclassified (pre-2012) ·initiated 21 Aug 2008

  Potential for table and stand not to move due to a software error.

• • Terminated Z-1642-2008 FDA Unclassified (pre-2012) ·initiated 14 Mar 2008 ·on shared 510(k) K041949

  Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.

• 2 recalls, same reason

  • Terminated Z-0162-2007 FDA Unclassified (pre-2012) ·initiated 24 Aug 2006
  • Terminated Z-0161-2007 FDA Unclassified (pre-2012) ·initiated 24 Aug 2006

  Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned.

• 2 recalls, same reason

  • Terminated Z-0208-06 FDA Unclassified (pre-2012) ·initiated 12 Oct 2005
  • Terminated Z-0209-06 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

K041949 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

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

See all devices from Philips Medical Systems North America, Inc. →