Azurion Azurion 7 M12 (REF 722078)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,087 adverse event reports that list this exact device (DI 00884838085251), received between Nov 14, 2019 and May 29, 2026 — classified as 2 deaths, 5 injuries, 1,080 malfunctions.

The most frequently reported specific device problem is “Radiation Output Failure” (514 reports).

24 FDA recall records name this device's identifier, 22 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

   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 ↗

5. 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 ↗

6. Mar 31, 2026Class IIOpen, Classified

   Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.

   Z-2170-2026 · Root cause: Device Design · Recall details · FDA record ↗

7. 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-1677-2026 · Root cause: Device Design · Recall details · FDA record ↗

8. 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-1348-2026 · Root cause: Device Design · Recall details · FDA record ↗

9. 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 ↗

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-2502-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. 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 ↗

12. 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-1093-2025 · Root cause: Device 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-1159-2025 · Root cause: Under Investigation by firm · 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-3165-2024 · Root cause: Device Design · Recall details · FDA record ↗

15. 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 ↗

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-1145-2024 · Root cause: Process design · Recall details · FDA record ↗

17. 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 ↗

18. 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 ↗

19. 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-2290-2026 · Root cause: Software 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-0559-2024 · Root cause: Device Design · Recall details · FDA record ↗

21. 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 ↗

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 12, 2021Class IITerminated

    (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available

    Z-0471-2022 · Root cause: Software design · Recall details · FDA record ↗

24. 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 1,087 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GENERATED A REMOTE ALERT INDICATING THE SESSION MANAGER HAD CRASHED, WHICH CAN IMPACT BOOTING. 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 25329772 ↗
• MalfunctionMay 14, 2026Activation Failure

  IT WAS REPORTED TO THE PHILIPS THAT THE SUITE COMPUTER WAS UNABLE TO BOOT UP, WHICH CAN IMPACT SYSTEM BOOTING. NO HARM TO THE USER OR PATIENT WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25170231 ↗
• MalfunctionMay 13, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE SYSTEM 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 25158202 ↗
• MalfunctionApr 30, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DID NOT START. THE SYSTEM WAS OUTSIDE OF CLINICAL USE WHEN THE ISSUE OCCURRED. 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 25051465 ↗
• MalfunctionApr 30, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE SYSTEM WAS OUT 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 25041629 ↗
• MalfunctionApr 28, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM¿S WIRELESS FOOT SWITCH WAS NOT WORKING, WHICH CAN IMPACT IMAGING. THERE WAS NO HARM REPORTED. PHILIPS HAS STARTED THE INVESTIGATION OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015051 ↗
• MalfunctionApr 24, 2026Activation Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THERE WAS AN INTERMITTENT ISSUE WITH THE SYSTEM'S SUITE COMPUTER, WHICH CAN IMPACT BOOTING. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24977721 ↗
• MalfunctionApr 14, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS GIVING ERRORS WHEN ATTEMPTING TO PERFORM IMAGING FROM THE FOOTSWITCH. 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 24875034 ↗
• MalfunctionApr 3, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PRODUCE X-RAYS. 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 24780483 ↗
• MalfunctionMar 23, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE GAVE AN ALERT FOR LOW SPACE IN DISK PARTITION, 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 24663459 ↗
• MalfunctionMar 18, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FLEXVISION COMPUTER HARD DRIVE WAS DEFECTIVE, PREVENTING A FULL SYSTEM BOOT. NO HARM TO THE PATIENT OR USER WAS REPORTED. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625844 ↗
• MalfunctionMar 16, 2026No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS DISPLAYING A BLUE SCREEN, PREVENTING 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 24605426 ↗
• MalfunctionMar 12, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. NO HARM WAS REPORTED TO PHILIPS. THE DEVICE WAS OUTSIDE OF 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 24581872 ↗
• MalfunctionMar 11, 2026Radiation Output Problem

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE REMOTE ALERTS INDICATING THERE WAS NO POINT CONNECTION TO THE X-SEGMENT CONTROLLER AND LOW LOAD FLUOROSCOPY WAS ACTIVE, WHICH CAN PREVENT 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 24567913 ↗
• MalfunctionMar 11, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING ONLY LOW LOAD FLUOROSCOPY WAS POSSIBLE, PREVENTING 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 24566725 ↗
• MalfunctionMar 4, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM FLUOROSCOPY AND CINE. 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 24504853 ↗
• MalfunctionFeb 23, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE CONTROL MODULE WAS DEFECTIVE. IT WAS NOT RESPONDING SPORADICALLY, PREVENTING GEOMETRY MOVEMENTS AND IMAGE ACQUISITION. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24417529 ↗
• MalfunctionFeb 23, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S UNINTERRUPTIBLE POWER SUPPLY HAD PROBLEM, WHICH COULD IMPACT 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 24414560 ↗
• MalfunctionFeb 23, 2026No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING THAT THE CURRENT DISPLAY WAS NOT SUPPORTED, PREVENTING IMAGING TO BE DISPLAYED. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411683 ↗
• MalfunctionFeb 19, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. 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 24394042 ↗
• MalfunctionFeb 10, 2026Unintended System Motion

  IT WAS REPORTED TO PHILIPS THAT DURING AN EMERGENT CORONARY ANGIOGRAPHY, WHILE THE TABLE WAS TILTED, THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). AT THE PHYSICIAN¿S REQUEST, CPR WAS TEMPORARILY PAUSED TO ALLOW IMAGING OF THE CORONARY ARTERIES. WHEN AN ATTEMPT WAS MADE TO REPOSITION THE TABLE, IT BEGAN TO FREE FLOAT. ACCORDING TO THE REPORT, ASSESSMENT OF THE PATIENT¿S CORONARY ARTERY STATUS WAS NOT POSSIBLE BECAUSE DISENGAGING THE TABLE MOTOR WOULD HAVE REQUIRED RESTARTING THE SYSTEM AND RE-ESTABLISHING THE IMAGING TABLE GEOMETRY, DURING WHICH CPR COULD NOT HAVE BEEN PERFORMED. CPR RESUMED, AND TWO NURSES MANUALLY HELD THE TABLE IN POSITION. THE REPORT FURTHER INDICATED THAT THE PATIENT PASSED AWAY; HOWEVER, NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO DATE. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307257 ↗
• MalfunctionFeb 5, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM HAD AUTOMATICALLY SHUT DOWN AND RESTARTED, WHICH CAN INDICATE A BOOTING ISSUE. 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 24267121 ↗
• MalfunctionFeb 5, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S UNINTERRUPTIBLE POWER SUPPLY HAD FAILED, WHICH CAN IMPACT A FULL SYSTEM BOOT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267118 ↗
• MalfunctionFeb 2, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FOOTSWITCH CHARGER WAS NOT WORKING, 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 24232138 ↗
• MalfunctionJan 29, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS NOT TURNING ON AFTER PRESSING POWER BUTTON ON REVIEW MODULE, PREVENTING A FULL SYSTEM BOOT. THE DEVICE WAS OUTSIDE OF 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 24218190 ↗