Allura Xper FD Allura Xper FD20/20Recalls & reported problems

Summary

The FDA's MAUDE database contains 250 adverse event reports that list this exact device (DI 00884838054226), received between Nov 4, 2021 and May 28, 2026 — classified as 2 injuries, 248 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (131 reports).

18 FDA recall records name this device's identifier, 18 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. 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-1669-2026 · Root cause: Device Design · Recall details · FDA record ↗

7. 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-1077-2026 · Root cause: Other · Recall details · FDA record ↗

8. 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-2630-2025 · Root cause: Device Design · Recall details · FDA record ↗

9. 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-0012-2026 · Root cause: Device Design · 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. 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 ↗

12. 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 ↗

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-1085-2025 · Root cause: Device Design · Recall details · FDA record ↗

14. Jan 13, 2025Class IOpen, Classified

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

    Z-1150-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

15. 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 ↗

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 ↗

17. 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 ↗

18. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 250 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT. 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 25319201 ↗
• MalfunctionFeb 25, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM GEOMETRY MOVEMENTS. THE DEVICE WAS 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 24449347 ↗
• MalfunctionJan 2, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS INTERMITTENTLY HANGING, WHICH CAN PREVENT A FULL SYSTEM BOOT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942408 ↗
• MalfunctionDec 31, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT, THE SYSTEM'S HOST COMPUTER WAS UNABLE TO BOOT, PREVENTING A FULL SYSTEM BOOT. THE DEVICE WAS OUTSIDE 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 23931800 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM SOFTWARE FAILED TO LOAD, CAUSING AN APPLICATION FREEZE ON AN ALLURA XPER FD20/20. 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 23593935 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THERE WAS A TEMPORARY STARTUP FAILURE ON HOST COMPUTER ON A ALLURA XPER FD20/20. 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 23592395 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE IPPC INTERMITTENTLY FAILS TO BOOT, PREVENTING EXPOSURE ON A ALLURA XPER FD20/20. 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 23592330 ↗
• MalfunctionNov 17, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM 3D ROTATIONAL MOVEMENTS. THE DEVICE WAS 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 23576411 ↗
• MalfunctionNov 17, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT SYSTEM BOOT STOP AT 0 SECOND. THIS IS CONNECTED TO STARTUP ISSUES RELATED TO A ALLURA XPER FD20/20. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568429 ↗
• MalfunctionNov 17, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT MACHINE IS AUTOMATICALLY SWITCHING OFF AND BOOTING ISSUE. THIS IS CONNECTED TO STARTUP ISSUES RELATED TO A ALLURA XPER FD20/20. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567726 ↗
• MalfunctionNov 13, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE X-RAY GENERATOR FAILURE CAUSED ABORTED VASCULAR PROCEDURE ON A ALLURA XPER FD20/20. 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 23540597 ↗
• MalfunctionNov 12, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT A STAND ROTATION ERROR OCCURRED DUE TO PROPELLER MOTOR FAILURE ON AN ALLURA XPER FD20/20. 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 23539245 ↗
• MalfunctionNov 12, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM COULD NOT START UP. THE DEVICE WAS OUTSIDE CLINICAL AT THE TIME OF THE 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 23538962 ↗
• MalfunctionNov 12, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT RENAL BIOPSY PROCEDURE THE TABLE¿S LONGITUDINAL MOVEMENT DID NOT PERFORM AS INTENDED WHICH DELAYED AN EXAMINATION. THE REPORT INDICATED THAT AN INJURY OCCURRED; HOWEVER, NO FURTHER DETAILS REGARDING THE ALLEGED INJURY HAVE BEEN PROVIDED AT THIS TIME. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

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

  MAUDE report 23535289 ↗
• MalfunctionNov 12, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT DURING A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACEMENT PROCEDURE THE TABLE¿S LONGITUDINAL MOVEMENT DID NOT PERFORM AS INTENDED WHICH DELAYED AN EXAMINATION. THE REPORT INDICATED THAT AN INJURY OCCURRED; HOWEVER, NO FURTHER DETAILS REGARDING THE ALLEGED INJURY HAVE BEEN PROVIDED AT THIS TIME. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

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

  MAUDE report 23534864 ↗
• MalfunctionNov 12, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT INTERMITTENT EXPOSURE FAILURE OCCURRED DURING IMAGING WORKFLOW ON AN ALLURA XPER FD20/20. 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 23530257 ↗
• MalfunctionNov 10, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT A GEOMETRY RESTARTING ERROR OCCURRED DUE TO MVR HIGH POWER BOARD FAILURE ON AN ALLURA XPER FD20/20. 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 23508607 ↗
• MalfunctionNov 10, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT GEOMETRY ERROR OCCURRED DUE TO MISMATCHED TABLE POTENTIOMETER ON A ALLURA XPER FD20/20. 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 23508603 ↗
• MalfunctionNov 7, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE PDM MODULE IN THE R CABINET FAILED DUE TO A POWER SUPPLY ISSUE ON AN ALLURA XPER FD20/20. 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 23498443 ↗
• MalfunctionNov 5, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT UP DUE TO A LICENSE CHECKING ERROR ON AN ALLURA XPER FD20/20. 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 23477400 ↗
• MalfunctionNov 5, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE TSM B SOFTWARE PROBLEM CAUSED SYSTEM RESTRICTION ON A ALLURA XPER FD20/20. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: Insufficient Information

  MAUDE report 23475310 ↗
• MalfunctionNov 5, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT A HARD DRIVE SPACE ISSUE CAUSED INTERMITTENT IMAGING FAILURES ON AN ALLURA XPER FD20/20. 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 23475010 ↗
• MalfunctionOct 31, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT LOW LOAD FLUORO ROTATOR ISSUE; UNABLE TO STORE IMAGES ON A ALLURA XPER FD20/20. 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 23435274 ↗
• MalfunctionOct 31, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT ON A ALLURA XPER FD20/20. 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 23434745 ↗
• MalfunctionOct 30, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FLEXVISION MONITOR HAD FLASHING COLORS AND WAS UNABLE TO DISPLAY LIVE IMAGES. THE DEVICE WAS INSIDE 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 23428500 ↗