Allura Xper FD Allura Xper FD10/10 (REF 722011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 449 adverse event reports that list this exact device (DI 00884838059047), received between Mar 10, 2021 and Mar 2, 2026 — classified as 449 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (231 reports).

10 FDA recall records name this device's identifier, 10 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-1662-2026 · 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-1069-2026 · 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-0003-2026 · 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-2624-2025 · Root cause: Device Design · Recall details · FDA record ↗

8. 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 ↗

9. 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 ↗

10. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 449 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM REQUIRES TWO BOOT ATTEMPTS IN THE MORNING BEFORE THE HOST COMPUTER STARTS UP SUCCESSFULLY. 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 24483214 ↗
• MalfunctionDec 8, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO START DUE TO LOW CMOS BATTERY ON A 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 23743343 ↗
• MalfunctionNov 25, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT GEO PC FAILED TO BOOT DURING USE 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 23643509 ↗
• MalfunctionNov 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT COLLIMATOR SHUTTERS WERE UNAVAILABLE AND GEOMETRY MOVEMENT WAS PARTLY AVAILABLE ON AN 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 23642887 ↗
• MalfunctionNov 24, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO PHILIPS THAT THE IMAGE SPACE WAS SLOW DURING NORMAL USE 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 23630341 ↗
• MalfunctionNov 20, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE UNIT FAILED TO POWER ON COMPLETELY; INTERMITTENT BOOT ISSUE 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 23605029 ↗
• MalfunctionNov 20, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT A GEOMETRY ERROR CAUSED MECHANICAL MOVEMENT ISSUES DURING 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: Insufficient Information

  MAUDE report 23603085 ↗
• MalfunctionNov 19, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO PHILIPS THAT THERE WAS A FLUORO IMAGE STORAGE ISSUE DURING 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 23595403 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE FLEXVISION MONITOR FAILED TO BOOT, AND A TEMPORARY STARTUP ISSUE WAS SUSPECTED 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 23593995 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT A LOW DISK SPACE ERROR OCCURRED DURING EQUIPMENT RESTART 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 23593981 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE FLEXPC FAILED TO BOOT DURING DEVICE INITIATION 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 23593497 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE STARTUP COUNTDOWN STOPPED AT 0:00, AND A FLEXVISION PC ISSUE WAS SUSPECTED ON A 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 23593071 ↗
• MalfunctionNov 19, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE FLEXVISION SCREEN FROZE DUE TO NETWORK COMMUNICATION LOSS 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 23593031 ↗
• MalfunctionNov 19, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT MONITOR FAILED TO DISPLAY AFTER REBOOT; ISSUE RESOLVED AFTER TESTING 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 23592510 ↗
• MalfunctionNov 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO PHILIPS THAT MOTOR MOVEMENT LIMITED; SYSTEM RESTART REQUIRED 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 23592407 ↗
• MalfunctionNov 18, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO START AT 'SYSTEM STARTING 0:00' 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 23590083 ↗
• MalfunctionNov 18, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO START DUE TO AN ERROR RELATED TO IMAGE TRANSFER AT STARTUP 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 23583212 ↗
• MalfunctionNov 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT GEOMETRY MOVEMENT WAS UNAVAILABLE DUE TO GEO PC FAILURE 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 23583202 ↗
• MalfunctionNov 18, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED TO PHILIPS THAT GEOMETRY PC FAILURE CAUSING UNINTENDED SYSTEM MOTION 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: Insufficient Information

  MAUDE report 23582085 ↗
• MalfunctionNov 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT GEOMETRY MOVEMENT WAS UNAVAILABLE DUE TO SUSPECTED GEO PC FAILURE 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 23582082 ↗
• MalfunctionNov 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT A GEO IPC WAS DEFECTIVE 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 23580192 ↗
• MalfunctionNov 13, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT, STALLING AT 00:00. 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 23548717 ↗
• MalfunctionNov 8, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE HOST PC FAILED TO BOOT BIOS, AND A BLANK MONITOR WAS OBSERVED 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 23505347 ↗
• MalfunctionNov 7, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE EXAMINATION ROOM FOOT SWITCH DID NOT RESPOND 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 23495299 ↗
• MalfunctionNov 7, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT AN IMAGE STORAGE ERROR PREVENTED IMAGING DURING 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 23494864 ↗