Allura Xper FD Allura Xper FD10/10 (REF 722027)Recalls & reported problems

Summary

The FDA's MAUDE database contains 603 adverse event reports that list this exact device (DI 00884838054196), received between Feb 2, 2018 and May 8, 2026 — classified as 603 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (334 reports).

19 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 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-1662-2026 · 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-1074-2026 · 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-2624-2025 · 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-0003-2026 · 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-1143-2025 · 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-1078-2025 · 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

    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. 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

    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 19, 2021Class IITerminated

    Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.

    Z-0416-2022 · Root cause: Other · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 603 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM BECAME UNRESPONSIVE AND COULD NOT PERFORM EXPOSURE. 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 25120842 ↗
• MalfunctionMay 4, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT DURING SYSTEM START-UP, WHICH COULD IMPACT BOOTING. 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 25069119 ↗
• MalfunctionMar 30, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO ACTIVATE X-RAYS. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728703 ↗
• MalfunctionMar 21, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING IT WAS CONNECTING TO THE HOST, PREVENTING THE SYSTEM FROM BOOTING. 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 24656596 ↗
• MalfunctionMar 10, 2026Activation Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM DID NOT BOOT UP SUCCESSFULLY. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559103 ↗
• MalfunctionMar 9, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S GEOMETRY COMPUTER WAS UNABLE TO BOOT, PREVENTING 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 24546675 ↗
• MalfunctionJan 13, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE DEVICE WAS OUTSIDE 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 24056748 ↗
• MalfunctionDec 24, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING THERE WAS A GEOMETRY ERROR. UPON REBOOTING, 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 23886187 ↗
• MalfunctionDec 12, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT PROPERLY. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790513 ↗
• MalfunctionNov 26, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FLEXVISION COMPUTER WAS UNABLE TO REACH TO THE HOST COMPUTER, PREVENTING THE SYSTEM FROM BOOTING. 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 23655393 ↗
• MalfunctionNov 25, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE DEVICE WAS OUTSIDE 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 23652566 ↗
• MalfunctionNov 25, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. NO HARM WAS REPORTED TO PHILIPS. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF REPORTED EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644433 ↗
• MalfunctionNov 24, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE FLEXVISION PC FAILED TO BOOT WITH 00:00 ERROR ON AN ALLURA XPER FD10/10. 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 23630337 ↗
• MalfunctionNov 24, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE WORKSTATION FAILED TO BOOT UP DURING THE SETUP PHASE ON AN ALLURA XPER FD10/10. 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 23629662 ↗
• MalfunctionNov 21, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT 'WIRELESS FOOTSWITCH CANNOT BE USED'. THIS IS CONNECTED TO LOSS OF IMAGE RELATED TO A ALLURA XPER FD10/10. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615019 ↗
• MalfunctionNov 20, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE X-RAY PC FAILED TO BOOT DURING CLINICAL USE ON AN ALLURA XPER FD10/10. 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 23603691 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM STUCK AT ZERO COUNTDOWN DURING BOOT-UP ON A ALLURA XPER FD10/10. 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 23597271 ↗
• MalfunctionNov 19, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT STORAGE NOT AVAILABLE ERROR PREVENTED IMAGING ON A ALLURA XPER FD10/10. 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 23595202 ↗
• MalfunctionNov 19, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT EXPOSURE WAS NOT POSSIBLE DUE TO AN IMAGE PROCESSING COMMUNICATION ERROR ON AN ALLURA XPER FD10/10. 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 23595193 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THERE WAS AN INTERMITTENT IPPC BOOT FAILURE; ACQUISITION DISK ERROR ON A ALLURA XPER FD10/10. 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 23595190 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT CONNECTION TO ALLURA FAILED; CORRUPT STARTUP REPORTED ON A ALLURA XPER FD10/10. 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 23592152 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT STARTUP FAILURE OF THE IMAGE STORAGE DEVICE OCCURRED, MAKING EXPOSURE NOT POSSIBLE ON A ALLURA XPER FD10/10. 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 23592149 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT, DISPLAYING A BLUE SCREEN DURING STARTUP ON A ALLURA XPER FD10/10. 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 23592145 ↗
• MalfunctionNov 18, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT FLEXVISION NOT TURNING ON. THIS IS CONNECTED TO STARTUP ISSUES RELATED TO A ALLURA XPER FD10/10. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582651 ↗
• MalfunctionNov 18, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THERE WAS A LOSS OF IMAGE MID-CASE, AND THE SYSTEM REQUIRED A REBOOT ON AN ALLURA XPER FD10/10. 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 23581001 ↗