Azurion Azurion 5 M12 (REF 722227)Recalls & reported problems

Summary

The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 00884838099227), received between Sep 15, 2021 and May 26, 2026 — classified as 1 death, 1 injury, 195 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (113 reports).

21 FDA recall records name this device's identifier, 20 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. 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 ↗

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-1679-2026 · 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-1350-2026 · Root cause: Device Design · Recall details · FDA record ↗

8. Dec 12, 2025Class IIOpen, Classified

   Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.

   Z-1113-2026 · Root cause: Software 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-1089-2025 · 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-1155-2025 · 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. Feb 6, 2024Class IIOpen, Classified

    Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

    Z-1177-2024 · Root cause: Under Investigation by firm · 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-2286-2026 · Root cause: Software design · Recall details · FDA record ↗

18. 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 ↗

19. 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 ↗

20. 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 ↗

21. 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 197 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026No Display/Image

  IT WAS REPORTED TO PHILIPS THAT SYSTEM'S FLEXVISION COMPUTER WAS BLACK DURING SYSTEM STARTUP. 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 25276529 ↗
• MalfunctionMay 20, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE FLEXVISION COMPUTER WOULD NOT TURN ON. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THERE WAS NO ALLEGATION OF INJURY TO THE PATIENT OR USER. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232458 ↗
• MalfunctionMay 19, 2026Unintended System Motion

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S TABLE PERFORMED AN UNCOMMANDED MOVEMENT. 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 25213437 ↗
• MalfunctionMay 15, 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 25181068 ↗
• MalfunctionMay 14, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS NOT SWITCHING ON. THE SYSTEM WAS NOT IN CLINICAL 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 25170383 ↗
• MalfunctionMay 12, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S UPS DID NOT WORK, PREVENTING A FULL SYSTEM BOOT. THE SYSTEM WAS OUTSIDE 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 25147280 ↗
• MalfunctionMay 8, 2026Unexpected Shutdown

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM HAD SHUT DOWN ON ITS OWN. 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 25125613 ↗
• MalfunctionMay 5, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS NOT PRODUCING X-RAYS. 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 25083322 ↗
• MalfunctionApr 29, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PRODUCE X-RAY WHILE OPENING A REFERENCE SCREEN ON FLEXVISION. 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 25030337 ↗
• MalfunctionApr 29, 2026No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM HAD TURNED OFF AGAIN DURING THE OPERATION, WHICH COULD IMPACT IMAGING. THE SYSTEM WAS IN CLINICAL 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 25030165 ↗
• MalfunctionApr 29, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE SYSTEM WAS NOT IN CLINICAL 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 25030158 ↗
• DeathApr 16, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT AT THE START OF AN EMERGENCY PERCUTANEOUS CORONARY INTERVENTION (PCI), THERE WAS AN ISSUE RELATED TO THE SYSTEM¿S X RAY EXPOSURE AND/OR GEOMETRY (TABLE) MOVEMENT, AND THAT PRIOR TO/SIMULTANEOUSLY WITH/AFTER THE ATTEMPT TO START THE PROCEDURE, THE PATIENT EXPERIENCED A CARDIAC ARREST AND REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). CPR WAS ADMINISTERED FOR APPROXIMATELY 45 MINUTES; HOWEVER, THE PATIENT COULD NOT BE RESUSCITATED. PHILIPS HAS INITIATED AN INVESTIGATION INTO THE REPORTED COMPLAINT, WHICH, AT THIS TIME, IS STILL CHARACTERIZED BY INCOMPLETE AND/OR SEEMINGLY CONFLICTING INFORMATION. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: Cardiac Arrest

  MAUDE report 24896723 ↗
• MalfunctionApr 6, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT 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 24788890 ↗
• MalfunctionMar 31, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING THE X-RAY TUBE COULD ONLY SUPPORT A LOW LOAD, PREVENTING CINE. 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 24740105 ↗
• MalfunctionMar 18, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO 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 24630056 ↗
• MalfunctionFeb 25, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DID NOT TURN ON. THE DEVICE USE WAS UNKNOWN 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 24442514 ↗
• MalfunctionFeb 20, 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 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 24399422 ↗
• MalfunctionFeb 17, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM 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 24364066 ↗
• MalfunctionFeb 6, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT DURING FLUOROSCOPY THE SYSTEM'S GENERATOR RESTARTED SPORADICALLY, WHICH COULD 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 24284264 ↗
• MalfunctionJan 23, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS HANGING, 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 24158561 ↗
• MalfunctionJan 19, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP PROPERLY. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24107518 ↗
• MalfunctionJan 6, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE DEVICE WAS OUTSIDE 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 23975667 ↗
• MalfunctionDec 25, 2025Activation Failure; Activation Failure

  IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM DID NOT BOOT UP SUCCESSFULLY. THE DEVICE 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 23892494 ↗
• MalfunctionDec 12, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM SOFTWARE APPLICATION WAS NOT BOOTING, PREVENTING A FULL SYSTEM BOOT. 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 23790514 ↗
• MalfunctionDec 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE A REMOTE ALERT INDICATING AN APPLICATION ERROR IN THE GEOMETRY, 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 23727544 ↗