AzurionRecalls & reported problems across all models

We found 22 models of Azurion by Philips Medical Systems Nederland B.V. in the FDA's device registry (GUDID). Together they are named in 9,199 adverse event reports in the FDA's MAUDE database, received between Feb 20, 2019 and Sep 30, 2026 — classified as 13 deaths, 54 injuries, 9,132 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3,557 reports).

71 FDA recall records name at least one of these models by its device identifier, 69 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Azurion recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 16, 2026Open, Classified

   Two software related issues affecting Philips Azurion R3.0 and R3.1 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-2932-2026 · Root cause: Software design · names 8 of these models · Recall details · FDA record ↗

2. 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 · names 14 of these models · Recall details · FDA record ↗

3. 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 · names 14 of these models · Recall details · FDA record ↗

4. 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 · names 14 of these models · Recall details · FDA record ↗

5. 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 · names 21 of these models · Recall details · FDA record ↗

6. 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 · names 10 of these models · Recall details · FDA record ↗

7. 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 · names 18 of these models · Recall details · FDA record ↗

8. 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 · names 7 of these models · Recall details · FDA record ↗

9. 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-1680-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

10. 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-1679-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

11. 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-1678-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

12. 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-1677-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

13. 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 · names 3 of these models · Recall details · FDA record ↗

14. 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-1675-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

15. 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-1674-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

16. 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-1673-2026 · Root cause: Device Design · Recall details · FDA record ↗

17. 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-1351-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

18. 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-1350-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

19. 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-1349-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

20. 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-1348-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

21. 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 · names 3 of these models · Recall details · FDA record ↗

22. 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-1346-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

23. 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-1345-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

24. 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-1344-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

25. Dec 12, 2025Open, 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 · names 16 of these models · Recall details · FDA record ↗

26. 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 · names 14 of these models · Recall details · FDA record ↗

27. Dec 8, 2025Open, Classified

    Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.

    Z-1079-2026 · Root cause: Software design · names 8 of these models · Recall details · FDA record ↗

28. 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 · names 14 of these models · Recall details · FDA record ↗

29. Jun 4, 2025Open, Classified

    Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

    Z-2134-2025 · Root cause: Device Design · Recall details · FDA record ↗

30. 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 · names 14 of these models · Recall details · FDA record ↗

…and 41 older recalls, listed on each model's page.

Most reported Azurion problems

Azurion models

22 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Azurion Azurion 7 M20

  Interventional Fluoroscopic X-Ray System
  32 recalls2 deaths2,308 reports
• Azurion Azurion 7 M20

  Interventional Fluoroscopic X-Ray System
  28 recalls1 death2,176 reports
• Azurion Azurion 7 M12

  Interventional Fluoroscopic X-Ray System
  24 recalls2 deaths1,087 reports
• Azurion Azurion 7 M12

  Interventional Fluoroscopic X-Ray System
  24 recalls2 deaths835 reports
• Azurion Azurion 7 B20

  Interventional Fluoroscopic X-Ray System
  24 recalls1 death634 reports
• Azurion Azurion 7 B20

  Interventional Fluoroscopic X-Ray System
  24 recalls594 reports
• Azurion Azurion 5 M20

  Interventional Fluoroscopic X-Ray System
  24 recalls201 reports
• Azurion Azurion 7 B12

  Interventional Fluoroscopic X-Ray System
  23 recalls232 reports
• Azurion Azurion 7 B12

  Interventional Fluoroscopic X-Ray System
  21 recalls222 reports
• Azurion Azurion 5 M12

  Interventional Fluoroscopic X-Ray System
  21 recalls1 death197 reports
• Azurion Azurion 3 M15

  Interventional Fluoroscopic X-Ray System
  20 recalls2 deaths205 reports
• Azurion Azurion 3 M15

  Interventional Fluoroscopic X-Ray System
  21 recalls104 reports
• Azurion Azurion 3 M12

  Interventional Fluoroscopic X-Ray System
  20 recalls121 reports
• Azurion Azurion 3 M12

  Interventional Fluoroscopic X-Ray System
  20 recalls73 reports
• Azurion Azurion 7 M20

  Interventional fluoroscopic x-ray system
  11 recalls1 death108 reports
• Azurion Azurion 7 B12

  Interventional fluoroscopic x-ray system
  11 recalls5 reports
• Azurion Azurion 7 B20

  Interventional fluoroscopic x-ray system
  10 recalls1 death50 reports
• Azurion Azurion 7 M12

  Interventional fluoroscopic x-ray system
  10 recalls27 reports
• Azurion Azurion 5 M20

  System, x-ray, fluoroscopic, image-intensified
  9 recalls7 reports
• Azurion Azurion 5 M12

  Interventional fluoroscopic x-ray system
  8 recalls8 reports
• Azurion Azurion 3 M15

  System, x-ray, fluoroscopic, image-intensified
  7 recalls1 report
• Azurion Azurion 3 M12

  System, x-ray, fluoroscopic, image-intensified
  6 recalls4 reports

Recent Azurion adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Activation Failure

  It was reported to Philips that the system did not boot. The system was not in clinical use at the time of the reported event. There was no allegation of injury.An investigation into this complaint has been initiated by Philips.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943965 ↗
• MalfunctionSep 30, 2026Activation Failure

  It was reported to Philips that the Angiograph system was not turning on.There was no harm reported. Philips has started an investigation of the complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943851 ↗
• MalfunctionSep 30, 2026Positioning Failure

  It was reported to Philips that the system was unable to perform motorized movement. 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 50943355 ↗
• MalfunctionSep 29, 2026Activation Failure

  It was reported to Philips that the system did not power on. The system was not in clinical use at the time of the reported event. There was no allegation of injury.An investigation into this complaint has been initiated by Philips.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935995 ↗
• MalfunctionSep 29, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928112 ↗
• MalfunctionSep 29, 2026Radiation Output Failure

  It was reported to Philips that artifacts were present in the image, preventing further imaging. 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 50927762 ↗
• MalfunctionSep 28, 2026Radiation Output Failure

  It was reported to Philips that the system was unable to expose, preventing imaging.The system was in clinical use at the time of the reported event. There was no harm reported. Philips has started an investigation of the complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916729 ↗
• MalfunctionSep 28, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916003 ↗
• MalfunctionSep 28, 2026Radiation Output Failure

  It was reported to Philips that the user was unable to release x-rays using wireless footswitch. There was no harm reported. Philips has started the investigation of the complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912427 ↗
• MalfunctionSep 28, 2026Positioning Failure

  It was reported to Philips that the system's c-arm was unable to perform geometry movements. No harm to the patient/user was reported. Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911661 ↗
• MalfunctionSep 26, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908368 ↗
• MalfunctionSep 26, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908226 ↗
• MalfunctionSep 25, 2026Radiation Output Failure

  It was reported to Philips that the system was unable to perform fluoroscopy and exposure.No harm was reported to Philips.Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896109 ↗
• MalfunctionSep 25, 2026Positioning Failure

  It was reported to Philips that the system's c-arm was unable to perform geometry movements following a reboot.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 50896107 ↗
• MalfunctionSep 25, 2026No Display/Image

  It was reported to Philips that images were not displayed on the monitor. 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 50895815 ↗

Other Philips Medical Systems Nederland B.V. products

• Allura Xper FD19 models · 15,187 reports · 84 recalls
• Ingenia54 models · 479 reports · 138 recalls
• IntelliSpace Cardiovascular11 models · 439 reports · 3 recalls
• MR 7000 Series2 models · 4 reports · 11 recalls
• Dynamic Coronary Roadmap3 models · 10 reports · 9 recalls
• MR 5000 Series3 models · 11 reports · 8 recalls
• Brilliance iCT2 models · 9 reports · 8 recalls
• Zenition2 models · 101 reports · 5 recalls