Allura Xper FD Allura Xper FD20/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 00884838054219), received between Sep 27, 2021 and May 27, 2026 — classified as 172 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (94 reports).

19 FDA recall records name this device's identifier, 19 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 29, 2026Class IIOpen, Classified

   Firmware issue potentially leading to loss of geometry movements.

   Z-2928-2026 · Root cause: Software design · Recall details · FDA record ↗

2. 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 ↗

3. 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 ↗

4. 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 ↗

5. 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 ↗

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-1076-2026 · 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-2632-2025 · 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-0009-2026 · Root cause: Device Design · Recall details · FDA record ↗

9. 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 ↗

10. 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 ↗

11. Jun 30, 2025Class IIOpen, Classified

    Potential for temporary loss of imaging (X-ray) functionality due to software issue.

    Z-2189-2025 · Root cause: Software design · Recall details · FDA record ↗

12. Jan 13, 2025Class IOpen, Classified

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

    Z-1148-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

13. Jan 13, 2025Class IIOpen, Classified

    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

    Z-1084-2025 · Root cause: Device Design · Recall details · FDA record ↗

14. 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 ↗

15. 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 ↗

16. 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 ↗

17. 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 ↗

18. Feb 2, 2022Class IIOpen, Classified

    Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.

    Z-0874-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

19. Nov 24, 2021Class IIOpen, Classified

    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.

    Z-0724-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 172 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SURVEILLANCE CAMERA FROZE AND, UPON REBOOTING, THE SYSTEM STALLED AT THE BIOS SCREEN AND FAILED TO FULLY BOOT. THE DEVICE WAS OUTSIDE OF CLINICAL USE WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT OR USER HARM REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303852 ↗
• MalfunctionMay 18, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM STARTUP STOPPED AT ¿00:00¿ AND THE FLEXVISION MONITOR SCREEN REMAINED BLACK. THE SYSTEM WAS OUTSIDE OF USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25198489 ↗
• MalfunctionMay 15, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT, STALLING AT THE COUNTDOWN TIMER. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186790 ↗
• MalfunctionMay 12, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM¿S REAR PANEL WAS NOT FUNCTIONING. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146235 ↗
• MalfunctionFeb 17, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S UNINTERRUPTIBLE POWER SUPPLY HAD A PROBLEM, PREVENTING THE SYSTEM FROM BOOTING. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364065 ↗
• MalfunctionJan 28, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S HOST COMPUTER WAS UNABLE TO BOOT, PREVENTING A FULL SYSTEM BOOT. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201855 ↗
• MalfunctionDec 8, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT DURING AN ANGIOGRAPHIC PROCEDURE, THE C-ARM DID NOT RETURN TO THE HOME POSITION. THE REPORT INDICATED THAT AN INJURY OCCURRED; HOWEVER, NO FURTHER DETAILS REGARDING THE ALLEGED INJURY HAVE BEEN PROVIDED TO DATE. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750893 ↗
• MalfunctionNov 19, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT FLUOROSCOPY LIVE IMAGES WERE BLACK IN CONTROL AND IMAGING ROOMS ON A ALLURA XPER FD20/10. 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 23594990 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO COMPLETE BOOTUP, STUCK AT LOGIN SCREEN ON AN ALLURA XPER FD20/10. 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 23592987 ↗
• MalfunctionNov 17, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT SYSTEM NOT BOOTING. THIS IS CONNECTED TO STARTUP ISSUES RELATED TO A ALLURA XPER FD20/10. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574472 ↗
• MalfunctionNov 17, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM STOPPED BOOTING ON 00:00, PREVENTING A FULL SYSTEM BOOT. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569019 ↗
• MalfunctionNov 10, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THERE WAS AN INTERMITTENT GEO-RESET BUTTON ISSUE, AND A SUSPECTED FAULTY GEO-MODULE WAS REPLACED ON A ALLURA XPER FD20/10. 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 23511421 ↗
• MalfunctionNov 10, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT FRONTAL RAO/LAO ROTATION FAILURE OCCURRED DUE TO BRAKE UNIT FAULT ON A ALLURA XPER FD20/10. 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 23510440 ↗
• MalfunctionNov 7, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO START DUE TO SUSPECTED VOLTAGE DROP ON A ALLURA XPER FD20/10. 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 23498439 ↗
• MalfunctionNov 7, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO POWER UP DUE TO DEFECTIVE 24V POWER SUPPLY ON A ALLURA XPER FD20/10. 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 23495691 ↗
• MalfunctionNov 6, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH SINGLE-SHOT FUNCTION WAS NOT WORKING ON AN ALLURA XPER FD20/10. 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 23484969 ↗
• MalfunctionNov 5, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM INTERMITTENTLY FAILED TO BOOT ON MONDAYS, REQUIRING A HOST PC RESET ON AN ALLURA XPER FD20/10. 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 23475523 ↗
• MalfunctionNov 5, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT ADU FAILURE CAUSED LATERAL IMAGE FAULTS AND A FUSE FAILURE ON AN ALLURA XPER FD20/10. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: Insufficient Information

  MAUDE report 23475199 ↗
• MalfunctionNov 5, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT POWER DOES NOT SHUT OFF WHEN PRESSING POWER OFF BUTTON ON A ALLURA XPER FD20/10. 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 23475120 ↗
• MalfunctionOct 30, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT A DISK ERROR OCCURRED DURING STARTUP, CAUSING THE SYSTEM TO FAIL TO BOOT INITIALLY ON A ALLURA XPER FD20/10. 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 23423378 ↗
• MalfunctionOct 24, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT, STALLING AT 00:00. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386273 ↗
• MalfunctionOct 21, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE FRONTAL HARD DISK DRIVE WAS FULL, CAUSING DELAYED SYSTEM STARTUP ON AN ALLURA XPER FD20/10. 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 23351026 ↗
• MalfunctionOct 21, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT; POWER SUPPLY AND HARD DISK WERE REPLACED ON A ALLURA XPER FD20/10. 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 23345812 ↗
• MalfunctionOct 17, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT OCCASIONAL IMAGE INTERRUPTION OCCURRED DURING LIVE CHANNEL USE ON AN ALLURA XPER FD20/10. 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 23325651 ↗
• MalfunctionOct 17, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE MACHINE FAILED TO POWER ON; TABLE HEIGHT DRIVE FOUND FAULTY ON A ALLURA XPER FD20/10. 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 23322362 ↗