Allura Xper FD Allura Xper FD20 OR Table (REF 722035)Recalls & reported problems

Summary

The FDA's MAUDE database contains 411 adverse event reports that list this exact device (DI 00884838054240), received between Jan 26, 2021 and Sep 30, 2026 — classified as 411 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (184 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 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-1665-2026 · Root cause: Device Design · Recall details · FDA record ↗

6. 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-0008-2026 · Root cause: Device Design · 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-2628-2025 · Root cause: Device Design · Recall details · FDA record ↗

8. 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 ↗

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. 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 ↗

11. Jan 13, 2025Class IOpen, Classified

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

    Z-1147-2025 · 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. 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 ↗

14. 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 ↗

15. 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 ↗

16. Nov 3, 2023Class IIOpen, Classified

    Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

    Z-0558-2024 · Root cause: Device Design · Recall details · FDA record ↗

17. Jun 12, 2023Class IIOpen, Classified

    The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

    Z-2283-2023 · Root cause: Component design/selection · 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 411 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Activation Failure

  It was reported to Philips that the system was experiencing booting issues.The system was not in clinical use during the event. No harm was reported to the user or the patient during the event.Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942592 ↗
• MalfunctionMay 27, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SCANNER WAS NOT WORKING WHILE A PATIENT WAS ON THE TABLE. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25298016 ↗
• MalfunctionMay 26, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GEOMETRY MOVEMENTS WERE NOT AVAILABLE. THE SYSTEM 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 25273824 ↗
• MalfunctionApr 24, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO EMIT X-RAYS, WHICH IMPACTED IMAGING. THE SYSTEM 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 24978672 ↗
• MalfunctionMar 3, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE A USER MESSAGE STATING FREE SPACE WAS LOW AND TO DELETE IMAGES. THE DEVICE WAS 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 24494845 ↗
• MalfunctionFeb 8, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FLEXVISION 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 24288259 ↗
• MalfunctionJan 30, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM HAD A GEOMETRY FAILURE. THE DEVICE WAS IN 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 24219402 ↗
• MalfunctionJan 22, 2026No Display/Image; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM COULD NOT EMIT X-RAY. THE DEVICE WAS 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 24142721 ↗
• MalfunctionJan 20, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH WAS NOT WORKING, WHICH CAN IMPACT IMAGING. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24113499 ↗
• MalfunctionDec 30, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE A REMOTE ALERT INDICATING THE IMAGE PROCESSING COMPUTER FAILED TO BOOT, WHICH CAN IMPACT IMAGING. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921648 ↗
• MalfunctionNov 28, 2025Positioning Failure; Positioning 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 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 23672236 ↗
• MalfunctionNov 21, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE FLEXMOVE POWER-UP FAILED, AND AN ERROR LOG WAS REVIEWED AND REBOOT PERFORMED ON AN ALLURA XPER FD20 OR TABLE. 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 23614531 ↗
• MalfunctionNov 20, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE X-RAY SAFETY LINE WAS ACTIVE AT STARTUP, MAKING EXPOSURE NOT POSSIBLE ON A ALLURA XPER FD20 OR TABLE. 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 23604127 ↗
• MalfunctionNov 20, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOT SWITCH SHOWED A RED WIFI MARK DUE TO A CONNECTION FAULT ON AN ALLURA XPER FD20 OR TABLE. 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 23603789 ↗
• MalfunctionNov 20, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THERE WAS INTERMITTENT LOSS OF LIVE IMAGE DUE TO FD CONTROLLER FAILURE ON AN ALLURA XPER FD20 OR TABLE. 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 23603222 ↗
• MalfunctionNov 19, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM 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 23596386 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT, WITH KEYBOARD LIGHTS AND SCREEN FLASHING, ON AN ALLURA XPER FD20 OR TABLE. 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 23595407 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT; SOFTWARE WAS REINSTALLED TO RESTORE FUNCTIONALITY ON A ALLURA XPER FD20 OR TABLE. 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 23592994 ↗
• MalfunctionNov 18, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT A TABLE BRAKE ERROR PREVENTED IMAGING DUE TO A SUSPECTED DATABASE/SOFTWARE ISSUE ON AN ALLURA XPER FD20 OR TABLE. 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 23582094 ↗
• MalfunctionNov 12, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING THE SMALL FOCUS OF THE FRONTAL X-RAY TUBE WAS DEFECTIVE, PREVENTING X-RAYS. THE DEVICE WAS IN CLINICAL USE 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 23530404 ↗
• MalfunctionNov 10, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT AMC DUAL AXIS DRIVE DEFECT CAUSED MOVEMENT ISSUES DURING USE ON A ALLURA XPER FD20 OR TABLE. 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 23510822 ↗
• MalfunctionNov 7, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT AN LVPS FAILURE CAUSED LOSS OF MOTORIZED MOVEMENT DURING SURGERY ON AN ALLURA XPER FD20 OR TABLE. 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 23497070 ↗
• MalfunctionNov 7, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT UNABLE TO GET IMAGES FROM MACHINE; CAUSE UNCLEAR ON A ALLURA XPER FD20 OR TABLE. 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 23495507 ↗
• MalfunctionNov 5, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT 3D IMAGE TRANSMISSION WAS SLOW; EXPOSURE HANDBRAKE NEEDED ON A ALLURA XPER FD20 OR TABLE. 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 23479863 ↗
• MalfunctionNov 5, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT A DISK FULL ERROR PREVENTED IMAGE STORAGE DURING A VASCULAR PROCEDURE ON A ALLURA XPER FD20 OR TABLE. 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 23477405 ↗