Allura Xper FD Allura Xper FD10 (REF 722010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,837 adverse event reports that list this exact device (DI 00884838059030), received between Jul 17, 2020 and May 22, 2026 — classified as 2 deaths, 5 injuries, 1,830 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (825 reports).

20 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 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 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-1661-2026 · Root cause: Device Design · Recall details · FDA record ↗

5. 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-1068-2026 · Root cause: Other · 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-0002-2026 · 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-2623-2025 · 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. 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-1077-2025 · Root cause: Device 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-1142-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

12. Nov 11, 2024Class IIOpen, Classified

    Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.

    Z-0676-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗

13. 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 ↗

14. May 16, 2024Class IIOpen, Classified

    When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

    Z-1896-2024 · Root cause: Under Investigation by firm · 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

    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 ↗

17. 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 ↗

18. 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 ↗

19. 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 ↗

20. 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 1,837 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE X-RAY SYSTEM WAS NOT WORKING. 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 25253304 ↗
• MalfunctionMar 30, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. 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 24715670 ↗
• MalfunctionJan 7, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM CINE. THE PATIENT WAS MOVED TO ANOTHER SYSTEM TO COMPLETE THE PROCEDURE. THE SYSTEM 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 23994731 ↗
• MalfunctionJan 6, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. 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 23975134 ↗
• MalfunctionDec 17, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING X-RAY TUBE CATHODE ERROR, IMPACTING IMAGING. 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 23830569 ↗
• MalfunctionDec 8, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE FLEXVISION PC FAILED TO POWER ON DUE TO DEFECTIVE CMOS BATTERY ON A ALLURA XPER FD10. 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 23743522 ↗
• MalfunctionDec 4, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S CONSOLE COMPUTER WAS UNABLE TO BOOT, PREVENTING A FULL SYSTEM BOOT. 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 23716406 ↗
• MalfunctionNov 25, 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 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 23644446 ↗
• MalfunctionNov 25, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE MACHINE FAILED TO SWITCH ON DUE TO A DEFECTIVE GEOPC ON AN ALLURA XPER FD10. 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 23642908 ↗
• MalfunctionNov 25, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT GEOIPC FAILURE CAUSED POSITIONING SYSTEM MALFUNCTION ON A ALLURA XPER FD10. 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 23642288 ↗
• MalfunctionNov 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS STUCK AT 00:00 DUE TO A DEFECTIVE GEOMETRY PC CAUSING L1 BREAKER TRIPS ON AN ALLURA XPER FD10. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE CLINICAL USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641985 ↗
• MalfunctionNov 25, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT BOOT-UP FAILURE OCCURRED DUE TO A DEFECTIVE PART ON A ALLURA XPER FD10. 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 23641981 ↗
• MalfunctionNov 24, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT X-RAY EMISSION WAS BLOCKED DUE TO DATABASE ERRORS ON A ALLURA XPER FD10. 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 23634165 ↗
• MalfunctionNov 24, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE EQUIPMENT FAILED TO BOOT AND WAS OUT OF SERVICE ON AN ALLURA XPER FD10. 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 23634164 ↗
• MalfunctionNov 24, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THERE WAS AN INTERMITTENT FLEXVISION BOOTING ISSUE OUTSIDE OF USE ON A ALLURA XPER FD10. 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 23631687 ↗
• MalfunctionNov 24, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT X-RAY EMISSION WAS BLOCKED DUE TO LACK OF STORAGE SPACE ON AN ALLURA XPER FD10. 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 23629650 ↗
• MalfunctionNov 24, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT X-RAY LOCKING OCCURRED DUE TO GENERATOR COMMUNICATION LOSS ON A ALLURA XPER FD10. 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 23629635 ↗
• MalfunctionNov 24, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE IMAGE DATABASE WAS FULL, RENDERING SYSTEM FLUOROSCOPY NON-FUNCTIONAL ON AN ALLURA XPER FD10. 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 23629545 ↗
• MalfunctionNov 24, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT A DISK FULL ERROR PREVENTED X-RAY DISABLING; DATABASE RECREATED ON A ALLURA XPER FD10. 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 23629165 ↗
• MalfunctionNov 24, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT A BLACK SCREEN ISSUE OCCURRED DURING CLINICAL USE ON AN ALLURA XPER FD10. 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 23629005 ↗
• MalfunctionNov 24, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FROZE MID-SCAN, CAUSING IMAGING FAILURE ON AN ALLURA XPER FD10. 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 23628846 ↗
• MalfunctionNov 21, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE HOST PC FAILED TO BOOT, AND AN ANTI-STATIC DISCHARGE TEMPORARILY RESOLVED THE ISSUE ON AN ALLURA XPER FD10. 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 23617751 ↗
• MalfunctionNov 21, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT GEOIPC COMMUNICATION FAILURE CAUSED THE DEVICE TO FAIL DURING CLINICAL USE ON AN ALLURA XPER FD10. 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 23615464 ↗
• MalfunctionNov 21, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT WORKSTATION NOT BOOTING; SOFTWARE RELOAD REQUIRED ON A ALLURA XPER FD10. 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 23615362 ↗
• MalfunctionNov 21, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT TABLE MOVEMENT WAS NOT FUNCTIONING DUE TO GEOIPC MANUAL POWER ISSUE ON AN ALLURA XPER FD10. 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 23615203 ↗