Allura Xper FD Allura Xper FD20/15 OR TableRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00884838059122), received between Jun 25, 2018 and Jan 13, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 reports).

12 FDA recall records name this device's identifier, 12 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-1672-2026 · 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-0011-2026 · 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-2634-2025 · 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. 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 ↗

10. 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 ↗

11. 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 ↗

12. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM C-ARM AND TABLE GEOMETRY MOVEMENTS. THE PROCEDURE WAS COMPLETED IN ANOTHER ROOM. 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 24058241 ↗
• MalfunctionSep 2, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT FLUOROSCOPY WAS LIMITED TO 10 MINUTES AND THE X-RAY STOPPED WORKING ON A ALLURA XPER FD20/15 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 22938646 ↗
• MalfunctionSep 2, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT GEOMETRY ERROR OCCURRED DUE TO BAD EXTENSION CABLE CONTACT ON A ALLURA XPER FD20/15 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 22938529 ↗
• MalfunctionJun 24, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT FOOT SWITCH CHARGER DEFECTED. THIS IS CONNECTED TO LOSS OF IMAGE RELATED TO A ALLURA XPER FD20/15 OR TABLE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318164 ↗
• MalfunctionFeb 13, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT WIRELESS FOOTSWITCH WILL NOT STAY CHARGED. THIS IS CONNECTED TO LOSS OF IMAGE RELATED TO A ALLURA XPER FD20/15 OR TABLE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21373879 ↗
• MalfunctionFeb 11, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT 'WFS BATTERY CHARGING PROBLEM'. THIS IS CONNECTED TO LOSS OF IMAGE RELATED TO A ALLURA XPER FD20/15 OR TABLE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356141 ↗
• MalfunctionOct 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM HAD A FRAYED CABLE THAT CAUSED THE TABLESIDE CONTROLS AND THE SYSTEM TO BECOME INOPERABLE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513156 ↗
• MalfunctionOct 9, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE C-ARM PROPELLER MOVEMENT WAS NOT WORKING PROPERLY. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE ISSUE DURING THE NEUROVASCULAR TREATMENT. THE PROCEDURE WAS COMPLETED AFTER CALIBRATING THE SYSTEM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND IDENTIFIED THAT THE CUSTOMER WAS UNABLE TO FULLY ROTATE THE FRONTAL C-ARM DETECTOR, WHICH RESULTED IN THE C-ARM PROPELLER BEING IMMOBILE. FSE CALIBRATED THE C-ARM. AFTER CALIBRATION, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20404880 ↗
• MalfunctionJul 10, 2024Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WOULD NOT BOOTUP. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS.PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLIANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709434 ↗
• MalfunctionOct 26, 2023Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT UP SUCCESSFULLY. THE SYSTEM WAS NOT IN CLINICAL USE. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18009391 ↗
• MalfunctionOct 19, 2023Activation Failure; Activation Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT UP. THE SYSTEM WAS NOT IN CLINICAL USE. THERE WAS NO REPORTED PATIENT OR USER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THE REPORTED PROBLEM. TROUBLESHOOTING ACTIONS SHOWED A PROBLEM WITH THE FLEXVISION PC. AFTER THE FLEXVISION PC WAS REPLACED AND THE SOFTWARE WAS REINSTALLED, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965067 ↗
• MalfunctionMay 10, 2023Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DID NOT START UP AND AFTER ONE HOUR THE SCREEN WAS STILL DISPLAYING "SYSTEM STARTING". SYSTEM WAS NOT IN CLINICAL USE. NO USER OR PATIENT HARM HAS BEEN REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND ASSISTED THE CUSTOMER WITH RELOADING THE SOFTWARE ON THE FLEXVISION-PC. THE DEVICE WAS RETURNED TO EXPECTED FUNCTIONALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908177 ↗
• MalfunctionFeb 15, 2023Activation Failure; Activation Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT, SYSTEM WAS HANG-UP. SYSTEM WAS NOT IN CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM AND FOUND THAT HOST PC PROBLEM. THEN FSE RE-INSTALLED THE HOST PC SOFTWARE AND SYSTEM IS WORKING AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379379 ↗
• MalfunctionDec 12, 2022Activation Failure; Activation Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM PRODUCED AN ERROR OF ¿GENERATOR BUSY¿ DURING START UP. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15961634 ↗
• MalfunctionMar 25, 2022Radiation Output Failure; Radiation Output Failure

  IT HAS BEEN REPORTED TO PHILIPS THE WIRELESS FOOTSWITCH WAS NOT CONNECTING TO THE ALLURA SYSTEM. THE SYSTEM WAS NOT IN CLINICAL USE WHEN THE ISSUE WAS IDENTIFIED. NO HARM HAS BEEN REPORTED TO PHILIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13899463 ↗
• MalfunctionJun 25, 2018Application Interface Becomes Non-Functional Or Program Exits Abnormally; Improper or Incorrect Procedure or Method; Device Displays Incorrect Message

  ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) PATIENT WAS ON X-RAY; TABLE: X-RAY. TABLE WAS UNABLE TO MOVE, FROZEN ERROR MESSAGE ABOUT GEOMETRY IS RESTING, ATTENDING WAS UNABLE TO CINE: CATHETER, WIRE WHERE IN PATIENT WHEN ROOM STARTING TO REBOOT. NEED AN OVERRIDE TO PREVENT IT IN FUTURE. THERE IS THE POSSIBILITY THAT THE EMERGENCY STOP BUTTON WAS PUSHED INADVERTENTLY WHICH WOULD CAUSE THIS EVENT. BMET AND PHILIPS SERVICE WERE CONTACTED TO SERVICE ROOM AND REVIEW ERROR MESSAGES FOR POTENTIAL CAUSES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7634064 ↗