Azurion Azurion 7 B20 (REF 722236)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00884838116801), received between Oct 11, 2024 and Sep 23, 2026 — classified as 1 death, 1 injury, 48 malfunctions.

The most frequently reported specific device problem is “Radiation Output Failure” (23 reports).

10 FDA recall records name this device's identifier, 10 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 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 · Recall details · FDA record ↗

2. 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 ↗

3. 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 ↗

4. 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 ↗

5. 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 ↗

6. 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 · Recall details · FDA record ↗

7. 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 · Recall details · FDA record ↗

8. 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 ↗

9. 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 ↗

10. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026No Display/Image

  It was reported to Philips that no image on the preview monitors. 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 50865278 ↗
• MalfunctionMay 29, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO POWER ON. THERE WAS NO HARM REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328538 ↗
• MalfunctionMay 22, 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 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 25253971 ↗
• MalfunctionMay 12, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM¿S L-ARC WAS UNABLE TO PERFORM GEOMETRY MOVEMENTS. THERE WAS NO HARM REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148495 ↗
• MalfunctionMay 6, 2026Image Display Error/Artifact

  IT WAS REPORTED TO PHILIPS THAT WHEN USING THE SMARTMASK FUNCTION DURING A PROCEDURE, THE IMAGES APPEARED NOISY AND DISPLAYED ARTIFACTS. THE SCAN WAS REPEATED TO OBTAIN BETTER IMAGES. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096309 ↗
• MalfunctionMay 6, 2026Erratic or Intermittent Display

  IT WAS REPORTED TO PHILIPS THAT DURING ENDOVASCULAR TREATMENT OF A CEREBRAL ANEURYSM, WHEN USING ROADMAP NAVIGATION, IMAGE SKIPPING OCCURRED. NO HARM WAS REPORTED TO PHILIPS. TO DATE, NO FURTHER INFORMATION WAS RECEIVED. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096105 ↗
• MalfunctionMay 6, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE STAND MOVEMENTS WERE PARTIALLY AVAILABLE. THERE WAS NO HARM REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092644 ↗
• MalfunctionApr 9, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH WAS INTERMITTENTLY UNABLE TO TRIGGER 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 24830825 ↗
• MalfunctionMar 19, 2026Entrapment of Device

  IT WAS REPORTED TO PHILIPS THAT THE USERS PINCHED THEIR FINGER IN THE GAP BETWEEN THE BED RAIL AND THE COVER DOOR WHILE MOVING THE BED. THE USER¿S FINGER WAS NOTED TO BE RED AND WAS TREATED BY COOLING, AND THE REDNESS WAS NOTED TO HAVE ALREADY DISSIPATED. THE SYSTEM WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THERE WAS NO ALLEGATION OF A SERIOUS INJURY TO THE PATIENT OR USER. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: Crushing Injury

  MAUDE report 24639503 ↗
• MalfunctionMar 16, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE TUBE OVERLOAD ALARM FOR THE LATERAL TUBE WAS TRIGGERED, CAUSING THE PATIENT TO BE RELOCATED TO ANOTHER DEVICE. 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 24610990 ↗
• MalfunctionMar 7, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE 3DRA OF PROPELLER ROTATION WAS NOT POSSIBLE. 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 24540457 ↗
• MalfunctionMar 2, 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 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 24484254 ↗
• MalfunctionFeb 26, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S 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 24464516 ↗
• MalfunctionJan 28, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT UPON PRESSING THE EMERGENCY STOP BUTTON TO CLEAR A GEOMETRY ERROR, THE UNINTERRUPTABLE POWER SUPPLY GAVE AN ERROR, PREVENTING THE SYSTEM FROM BOOTING BACK UP. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197257 ↗
• MalfunctionJan 28, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM GEOMETRY MOVEMENTS, AND THE SHUTTER GAVE AN ERROR INDICATING THE POSITION WAS UNKNOWN. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197256 ↗
• InjuryJan 23, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT DURING A CEREBRAL ANEURYSM EMBOLIZATION USING AN INTRASACCULAR FLOW DISRUPTOR DEPLOYED UNDER ROADMAP FLUOROSCOPY, THE DEVICE WAS DIFFICULT TO VISUALIZE UNDER BOTH ROADMAP AND NATIVE FLUOROSCOPY. AFTER DEPLOYMENT, 2D DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND VASOCT WERE PERFORMED TO CONFIRM PLACEMENT, REVEALING THAT THE DEVICE WAS MAL-POSITIONED AND OCCLUDED A NON-TARGET VESSEL. ADDITIONAL TREATMENT WAS REQUIRED TO UNBLOCK THE OCCLUDED VESSEL, EXTENDING THE PROCEDURE BY APPROXIMATELY 1.5 HOURS. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24160848 ↗
• MalfunctionJan 22, 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 24147459 ↗
• MalfunctionDec 3, 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 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 23704872 ↗
• MalfunctionDec 3, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FLEXVISION MONITOR WAS UNABLE TO DISPLAY IMAGES. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703980 ↗
• MalfunctionDec 2, 2025Radiation Output Failure; Radiation Output Failure

  WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH WAS NOT RESPONDING, 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 23696511 ↗
• MalfunctionDec 1, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE GEOMETRY ERRORS, PREVENTING 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 23682270 ↗
• MalfunctionNov 26, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S COLLIMATOR WAS STUCK, WHICH COULD IMPACT 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 23658783 ↗
• MalfunctionNov 20, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S MONITOR WAS UNABLE TO DISPLAY 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 23612705 ↗
• MalfunctionNov 10, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE AUTOMATIC POSITION CONTROL ACCEPT BUTTON WAS PRESSED MULTIPLE TIMES, PREVENTING 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 23509283 ↗
• MalfunctionOct 20, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH WAS UNABLE TO TRIGGER X-RAYS 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 23341732 ↗