Allura Xper FD Allura Xper FD20 (REF 722028)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,984 adverse event reports that list this exact device (DI 00884838054202), received between Jun 4, 2019 and Sep 29, 2026 — classified as 2 deaths, 23 injuries, 3,959 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1,867 reports).

25 FDA recall records name this device's identifier, 23 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 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 ↗

6. 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-1663-2026 · Root cause: Device Design · Recall details · FDA record ↗

7. 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-1075-2026 · Root cause: Other · 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-0005-2026 · Root cause: Device Design · Recall details · FDA record ↗

9. 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-2626-2025 · Root cause: Device Design · 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. 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 ↗

12. 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 ↗

13. Jan 13, 2025Class IOpen, Classified

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

    Z-1144-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

14. 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-1080-2025 · Root cause: Device Design · Recall details · FDA record ↗

15. 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-1081-2025 · Root cause: Device Design · Recall details · FDA record ↗

16. 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 ↗

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. 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 ↗

19. 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 ↗

20. 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 ↗

21. 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 ↗

22. 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 ↗

23. Nov 24, 2021Class IIOpen, Classified

    Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

    Z-0724-2022 · Root cause: Process control · Recall details · FDA record ↗

24. 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 ↗

25. Sep 24, 2021Class IITerminated

    When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.

    Z-0213-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 3,984 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 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 to Philips.Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929518 ↗
• MalfunctionSep 29, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929402 ↗
• MalfunctionSep 29, 2026Radiation Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929182 ↗
• MalfunctionSep 29, 2026Radiation Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929181 ↗
• MalfunctionSep 29, 2026No Display/Image

  It was reported to Philips that the Flexvision monitor was unable to display 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 50929180 ↗
• MalfunctionSep 29, 2026Unexpected Deactivation

  It was reported to Philips that there was smoke inside the cabinet room.The system was not in clinical use during the event. No harm was reported to Philips or the patient during the event.Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927823 ↗
• MalfunctionSep 28, 2026Positioning Failure

  It was reported to Philips that the C-arm of the system moves in the opposite direction.The system was in clinical use at the time of the event. No harm to the patient or user was reported to Philips.Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913559 ↗
• MalfunctionSep 25, 2026Insufficient Device Problem Information

  It was reported to Philips that the Wall connection box was defective.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 50896674 ↗
• MalfunctionSep 25, 2026Activation Failure

  It was reported to Philips that the Host computer was unable to boot up.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 50894804 ↗
• MalfunctionSep 24, 2026Activation Failure

  It was reported to Philips that the system could not start up.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 50878072 ↗
• MalfunctionSep 23, 2026Radiation Output Failure

  It was reported to Philips the system was unable to perform Xray. no harm was reported to Philips.Philips has started investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871721 ↗
• MalfunctionSep 23, 2026Activation Failure

  It was reported to Philips that the system could not start up. The system was outside of clinical use at the time of the event. No harm to the patient or user was reported to Philips.Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866239 ↗
• DeathAug 26, 2026Radiation Output Failure

  It was reported to Philips that during an emergency cerebral infarction thrombectomy procedure, the system was unable to emit X-rays and images could not be viewed. A system restart was attempted; however, the issue persisted. The patient was transferred to another system, and the procedure was completed. The reported system issue reportedly resulted in a delay of approximately 50 minutes. It was also reported that severe thrombosis was observed after the guidewire had been inserted.The patient remained in critical condition following the procedure and was subsequently discharged at the family's request. The patient was reportedly alive and not any life-support equipment at the time of discharge. It was subsequently reported that the patient passed away; however, the date and cause of death remain unknown. An investigation into this complaint has been initiated by Philips.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50451544 ↗
• MalfunctionJul 30, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50080349 ↗
• MalfunctionMay 29, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM CINE. THE SYSTEM 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 25328984 ↗
• MalfunctionMay 28, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING THE DISK WAS FULL, WHICH CAN IMPACT IMAGING. THE SYSTEM 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 25312029 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO PHILIPS THAT LOOSE SCREWS ON THE TABLE RADIATION SHIELD/LEAD CURTAIN CAUSED SCRATCHES TO THE OPERATOR¿S HAND. THE ISSUE WAS IDENTIFIED AFTER THE PROCEDURE WHILE TRANSFERRING THE PATIENT, WHEN THE DOCTOR SUSTAINED A CUT/SCRATCH FROM THE LOOSE SCREWS. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: Abrasion

  MAUDE report 25299241 ↗
• MalfunctionMay 26, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT SYSTEM WAS UNABLE TO CAPTURE 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 25278084 ↗
• MalfunctionMay 26, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DISPLAYED AN IMAGE DISK FULL/DATABASE ERROR AND WAS UNABLE TO ACQUIRE OR STORE IMAGES. THE SYSTEM 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 25274271 ↗
• MalfunctionMay 25, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT FOLLOWING INSTALLATION OF A SOFTWARE UPDATE, THE SYSTEM FAILED TO INITIALIZE, RESULTING IN LOSS OF FUNCTIONALITY. THE SYSTEM 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 25267612 ↗
• MalfunctionMay 19, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM HAD INTERMITTENT BOOTUP ISSUE. THE SYSTEM WAS OUTSIDE OF CLINICAL USE. 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 25214015 ↗
• MalfunctionMay 18, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM WAS UNABLE TO PERFORM GEOMETRY MOVEMENTS. THE PATIENT WAS MOVED TO ANOTHER ROOM. 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 25203536 ↗
• MalfunctionMay 18, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM UNABLE TO BOOT, STALLING AT 00:00. THE SYSTEM 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 25198800 ↗
• MalfunctionMay 18, 2026Image Display Error/Artifact

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S X-RAY TUBE WAS ARCING. 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 25198302 ↗
• MalfunctionMay 18, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE SYSTEM 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 25197565 ↗