Azurion Azurion 3 M15 (REF 722064)Recalls & reported problems

Summary

The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 00884838085282), received between Aug 20, 2020 and Apr 15, 2026 — classified as 2 deaths, 203 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (88 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. Jul 16, 2026Class IIOpen, Classified

   Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

   Z-2931-2026 · 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-2892-2026 · 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-2258-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Apr 28, 2026Class IIOpen, Classified

   Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.

   Z-2225-2026 · Root cause: Device Design · Recall details · FDA record ↗

5. 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-2227-2026 · Root cause: Component design/selection · 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-1674-2026 · Root cause: Device Design · Recall details · FDA record ↗

7. Jan 26, 2026Class IIOpen, Classified

   Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

   Z-1345-2026 · Root cause: Device Design · Recall details · FDA record ↗

8. Dec 12, 2025Class IIOpen, Classified

   Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

   Z-1091-2026 · Root cause: Software design · 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-2502-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. May 28, 2025Class IIOpen, Classified

    A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

    Z-1969-2025 · Root cause: Software design · Recall details · FDA record ↗

11. 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-1088-2025 · Root cause: Device 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-1154-2025 · Root cause: Under Investigation by firm · 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-3165-2024 · Root cause: Device Design · Recall details · FDA record ↗

14. Jul 15, 2024Class IIOpen, Classified

    Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart

    Z-2534-2024 · 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-1152-2024 · Root cause: Process design · Recall details · FDA record ↗

16. Dec 12, 2023Class IIOpen, Classified

    System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.

    Z-0835-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

17. Dec 7, 2023Class IIOpen, Classified

    During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

    Z-2285-2026 · Root cause: Software design · Recall details · FDA record ↗

18. Mar 21, 2023Class IIOpen, Classified

    Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

    Z-1647-2023 · Root cause: Under Investigation by firm · 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. 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 205 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT INTERMITTENTLY, THE SYSTEM GEOMETRY MOVEMENTS WERE NOT AVAILABLE. 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 24884486 ↗
• MalfunctionApr 1, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM COULD NOT EMIT X-RAY. 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 24752599 ↗
• MalfunctionMar 10, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT. 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 24559093 ↗
• MalfunctionMar 4, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. NO HARM WAS REPORTED TO PHILIPS. THE DEVICE WAS 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 24506064 ↗
• MalfunctionFeb 18, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM LOST THE LIVE IMAGE. 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 24377950 ↗
• MalfunctionFeb 8, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PRODUCE X-RAYS.THE DEVICE 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 24288260 ↗
• MalfunctionJan 30, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRED FOOTSWITCH CABLE HAD DAMAGED, WHICH CAN IMPACT THE IMAGING. 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 24219639 ↗
• MalfunctionJan 28, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM COULD NOT EMIT X-RAY. THE DEVICE WAS IN 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 24197386 ↗
• MalfunctionJan 20, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S SOFTWARE HAD PROBLEM, WHICH COULD IMPACT BOOTING. THE DEVICE WAS OUTSIDE 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 24121375 ↗
• MalfunctionJan 20, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THERE WAS AN ISSUE WITH THE SYSTEM'S GEOMETRY MODULE, WHICH CAN IMPACT 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 24113495 ↗
• MalfunctionJan 12, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S X-RAY TUBE WAS DEFECTIVE, WHICH CAN IMPACT IMAGING. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24034924 ↗
• MalfunctionJan 9, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM COULD NOT EMIT X-RAY. 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 24017787 ↗
• MalfunctionDec 31, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE DEVICE WAS OUTSIDE OF 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 23933346 ↗
• MalfunctionDec 26, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING X-RAYS WERE NOT POSSIBLE, WHICH CAN IMPACT 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 23898012 ↗
• MalfunctionDec 24, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT DURING A CORONARY ANGIOGRAPHY PROCEDURE, THE SYSTEM PRODUCED DARK IMAGES. THE SYSTEM WAS RESTARTED TWICE WITHOUT RESOLVE. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER A THIRD RESTART OF THE SYSTEM. THERE WAS NO REPORTED PATIENT OR USER HARM. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887966 ↗
• MalfunctionDec 24, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S COLLIMATOR CLOSED UNEXPECTEDLY, WHICH CAN IMPACT IMAGING. NO HARM WAS REPORTED TO PHILIPS. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887741 ↗
• MalfunctionDec 17, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO START DUE TO UPS CONTROLLER AND BURNT FUSE ON A AZURION 3 M15. 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 23826473 ↗
• MalfunctionDec 12, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S TABLE SIDE OPERATING MODULE BUTTON HAD BEEN ACTIVATED, WHICH CAN IMPACT THE SYSTEM FROM BOOTING. THE DEVICE WAS OUTSIDE OF 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 23787688 ↗
• MalfunctionDec 9, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM COULD NOT START 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 23754535 ↗
• MalfunctionDec 8, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE A REMOTE ALERT INDICATING A GEOMETRY SEGMENT CONTROLLER ERROR, WHICH CAN IMPACT THE 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 23739862 ↗
• MalfunctionDec 8, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM COULD NOT EMIT X-RAY. THE DEVICE WAS IN 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 23739717 ↗
• MalfunctionDec 5, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM SOFTWARE FAILED. 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 23725219 ↗
• MalfunctionDec 4, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S GEOMETRY MOVEMENTS WERE UNAVAILABLE. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717198 ↗
• MalfunctionDec 1, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM SOFTWARE WAS UNABLE TO BOOT UP. THE DEVICE WAS OUTSIDE 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 23679844 ↗
• MalfunctionNov 24, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM WAS UNABLE TO PERFORM 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 23629094 ↗