Azurion Azurion 7 B20 (REF 722068)Recalls & reported problems

Summary

The FDA's MAUDE database contains 594 adverse event reports that list this exact device (DI 00884838085367), received between Feb 20, 2019 and May 27, 2026 — classified as 4 injuries, 590 malfunctions.

The most frequently reported specific device problem is “Radiation Output Failure” (237 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 16, 2026.

Recalls naming this device

1. Jul 16, 2026Open, 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, 2026Open, 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, 2026Open, 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, 2026Open, 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, 2026Open, 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 31, 2026Open, 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 19, 2026Open, 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 ↗

8. Mar 3, 2026Open, Classified

   Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

   Z-1676-2026 · Root cause: Device Design · Recall details · FDA record ↗

9. Jan 26, 2026Open, Classified

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

   Z-1347-2026 · Root cause: Device Design · Recall details · FDA record ↗

10. Dec 12, 2025Open, 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 ↗

11. Aug 1, 2025Open, 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 ↗

12. May 28, 2025Open, 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 ↗

13. Jan 13, 2025Open, Classified

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

    Z-1158-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

14. Jan 13, 2025Open, 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-1092-2025 · Root cause: Device Design · Recall details · FDA record ↗

15. Aug 22, 2024Open, 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 ↗

16. Jul 15, 2024Open, 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 ↗

17. Jan 2, 2024Open, 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. Jan 2, 2024Open, 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 ↗

19. Dec 12, 2023Open, 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 ↗

20. Dec 7, 2023Open, 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-2289-2026 · Root cause: Software design · Recall details · FDA record ↗

21. Mar 21, 2023Open, 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, 2022Open, 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, 2021Terminated

    (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, 2021Terminated

    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 594 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THERE WAS AN ISSUE WITH THE COLLIMATOR MOVEMENTS. NO PATIENT OR USER HARM WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. DUE TO THE LACK OF INFORMATION, WE ARE CONSERVATIVELY REPORTING THIS EVENT. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305953 ↗
• MalfunctionMay 22, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT SYSTEM WAS NOT BOOTING UP PROPERLY. 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 25252518 ↗
• MalfunctionMay 19, 2026No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE FLEXVISION MONITOR WAS NOT DISPLAYING. THERE WAS NO HARM REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215128 ↗
• MalfunctionMay 13, 2026Activation 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 25157595 ↗
• MalfunctionMay 12, 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 25148105 ↗
• MalfunctionMay 12, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING THE LOW LOAD FLUOROSCOPY FLAVOR WAS SELECTED. 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 25146516 ↗
• MalfunctionMay 4, 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 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 25067967 ↗
• MalfunctionApr 27, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ERROR REGARDING POWER CONTROL BOARD PDU DUAL SWITCH MODULE, THAT IMPACTED THE WHOLE SYSTEM BOOT UP. THERE WAS NO INFORMATION REGARDING THE DEVICE USE DURING THE TIME OF THE REPORTED MALFUNCTION. THERE WAS NO HARM REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24994851 ↗
• MalfunctionApr 22, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO POWER ON. 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 24949958 ↗
• MalfunctionApr 21, 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 24940723 ↗
• MalfunctionApr 14, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING EXPOSURE PREPARATION FAILED, WHICH CAN IMPACT IMAGING. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877942 ↗
• MalfunctionMar 20, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE FLEXVISION COMPUTER WAS NOT WORKING WHICH CAN IMPACT BOOTING. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647220 ↗
• MalfunctionMar 13, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT A MESSAGE STATING ACTIVE BUTTON DETECTED ON CONTROL MODULE WAS DISPLAYED DURING STARTUP, WHICH CAN IMPACT SYSTEM 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 24596197 ↗
• MalfunctionFeb 24, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. 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 24437337 ↗
• MalfunctionFeb 13, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM GEOMETRY MOVEMENTS. 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 24338817 ↗
• MalfunctionFeb 10, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE ALERTS INDICATING ONLY LOW LOAD FLUOROSCOPY WAS SELECTED AND THE GENERATOR WAS BUSY, PREVENTING 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 24302794 ↗
• MalfunctionJan 27, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH WAS UNABLE TO TRIGGER FLUOROSCOPY. 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 24187172 ↗
• MalfunctionJan 27, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH WAS UNABLE TO TRIGGER FLUOROSCOPY. 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 24187168 ↗
• MalfunctionJan 27, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRED FOOTSWITCH WAS UNABLE TO TRIGGER FLUOROSCOPY. 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 24187163 ↗
• MalfunctionJan 19, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S CONTROL MODULE GEOMETRY WAS DAMAGED, WHICH CAN IMPACT 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 24107519 ↗
• MalfunctionJan 14, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO COMPLETELY BOOT. THE USER REBOOTED THE SYSTEM TWICE, BUT THE ISSUE PERSISTED. 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 24072064 ↗
• MalfunctionJan 12, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING THAT MULTIPLE FOCUS WAS NOT AVAILABLE, WHICH CAN IMPACT THE 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 24033476 ↗
• MalfunctionJan 8, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM 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 24004158 ↗
• MalfunctionDec 28, 2025Activation Failure; Activation Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM DID NOT BOOT 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 23903913 ↗
• MalfunctionDec 22, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH'S FLUOROSCOPY PEDAL WAS NOT FUNCTIONING, WHICH CAN IMPACT IMAGING. 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 23872758 ↗