Allura Xper FD Allura Xper FD20 BiplaneRecalls & reported problems

Summary

The FDA's MAUDE database contains 792 adverse event reports that list this exact device (DI 00884838059061), received between Oct 16, 2020 and Dec 8, 2025 — classified as 3 deaths, 3 injuries, 786 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (406 reports).

16 FDA recall records name this device's identifier, 16 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 17, 2026Class IIOpen, Classified

   Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

   Z-2891-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Apr 30, 2026Class IIOpen, Classified

   It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

   Z-2259-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Apr 28, 2026Class IIOpen, Classified

   The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

   Z-2228-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

4. Mar 19, 2026Class IIOpen, Classified

   Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.

   Z-1805-2026 · Root cause: Labeling design · Recall details · FDA record ↗

5. Mar 3, 2026Class IIOpen, Classified

   Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

   Z-1664-2026 · Root cause: Device Design · Recall details · FDA record ↗

6. Dec 15, 2025Class IIOpen, Classified

   Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

   Z-1071-2026 · Root cause: Other · Recall details · FDA record ↗

7. Sep 3, 2025Class IIOpen, Classified

   Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

   Z-2627-2025 · Root cause: Device Design · Recall details · FDA record ↗

8. Sep 3, 2025Class IIOpen, Classified

   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.

   Z-0006-2026 · Root cause: Device Design · Recall details · FDA record ↗

9. Aug 1, 2025Class IIOpen, Classified

   Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

   Z-2503-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. Aug 1, 2025Class IIOpen, Classified

    Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

    Z-2504-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. Jan 13, 2025Class IOpen, Classified

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

    Z-1145-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

12. Aug 22, 2024Class IIOpen, Classified

    Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

    Z-3166-2024 · Root cause: Device Design · Recall details · FDA record ↗

13. May 16, 2024Class IIOpen, Classified

    When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

    Z-1897-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

14. Jan 2, 2024Class IIOpen, Classified

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

    Z-1151-2024 · Root cause: Process design · Recall details · FDA record ↗

15. Jan 2, 2024Class IIOpen, Classified

    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.

    Z-1144-2024 · Root cause: Process design · Recall details · FDA record ↗

16. Jan 2, 2024Class IIOpen, Classified

    Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

    Z-1156-2024 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 792 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT HOST PC BOOT FAILURE DUE TO CMOS BATTERY ISSUE ON A ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743265 ↗
• MalfunctionDec 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM GEOMETRY MOVEMENTS. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724819 ↗
• MalfunctionNov 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT A GEOMETRY ERROR OCCURRED AT STARTUP DUE TO IPC FAILURE ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641983 ↗
• MalfunctionNov 24, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THERE WAS AN IMAGE STORAGE FAILURE DURING DEVICE USE ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629541 ↗
• MalfunctionNov 24, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM EXPERIENCED A STARTUP ISSUE RESOLVED BY FLEXVISION SOFTWARE RELOAD ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629168 ↗
• MalfunctionNov 21, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT BODYGUARD MESSAGE APPEARS WHEN TABLE IS LOWERED ON A ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23614652 ↗
• MalfunctionNov 20, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO MAKE X-RAY EXPOSURES DUE TO AN ISSUE IN X-RAY GENERATION ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605024 ↗
• MalfunctionNov 20, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE HOST PC INTERMITTENTLY FAILED TO POWER UP ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604836 ↗
• MalfunctionNov 20, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT A HARD DISK ERROR CAUSED IMAGING SYSTEM FAILURE ON A ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604634 ↗
• MalfunctionNov 20, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT AN X-RAY GENERATOR ERROR CAUSED DELAYED LATERAL IMAGE DISPLAY ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604383 ↗
• MalfunctionNov 20, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT CALIBRATION FAILED DURING STARTUP DUE TO IP PCS NOT BEING OPERATIONAL ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604126 ↗
• MalfunctionNov 20, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT A DISK FULL ERROR CAUSED STORAGE AND COMMUNICATION ISSUES ON A ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS UNKNOWN. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603461 ↗
• MalfunctionNov 19, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED TO PHILIPS THAT EQUIPMENT STARTUP WAS SLOW; LOGS SHOWED ARCHIVING ISSUES ON A ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595767 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT NETWORK SWITCH AND IMAGE DISK ERRORS CAUSED SYSTEM MALFUNCTION ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592954 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT, DISPLAYING BLUE SCREEN OF DEATH ON A ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592841 ↗
• MalfunctionNov 19, 2025Activation Problem; Activation Problem

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS STUCK AT 0:00 DUE TO FLEXVISION PC COMMUNICATION FAILURE ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592387 ↗
• MalfunctionNov 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT GEOMETRY IPC ERRORS OCCURRED POST REPLACEMENT, INCLUDING CLEA EXT PCB POST FAILURES ON A ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590343 ↗
• MalfunctionNov 18, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT SYSTEM FAILS TO START AFTER OPENING APPLICATION ON A ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583211 ↗
• MalfunctionNov 18, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE HOST PC WAS UNABLE TO COMMUNICATE WITH GEOIPC DURING POST ON A ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582652 ↗
• MalfunctionNov 18, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT FOOTSWITCH NOT WORKING INTERMITTENTLY. THIS IS CONNECTED TO LOSS OF IMAGE RELATED TO A ALLURA XPER FD20 BIPLANE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582649 ↗
• MalfunctionNov 18, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT EXPOSURE NOT POSSIBLE. THIS IS CONNECTED TO STARTUP ISSUES RELATED TO A ALLURA XPER FD20 BIPLANE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582648 ↗
• MalfunctionNov 18, 2025Activation Problem; Activation Problem

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO START; DELAYED POWER-OFF AND RESTART IMPROVED SITUATION ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS UNKNOWN. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582256 ↗
• MalfunctionNov 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT AN IPC COMMUNICATION ISSUE OCCURRED, REQUIRING GEO IPC REPLACEMENT AND SOFTWARE REINSTALLATION ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581264 ↗
• MalfunctionNov 18, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT DUE TO A SUSPECTED INTERNAL SWITCH ISSUE ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580811 ↗
• MalfunctionNov 18, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT; ROOT CAUSE UNCLEAR ON AN ALLURA XPER FD20 BIPLANE. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580792 ↗