Azurion Azurion 7 M20 (REF 722234)Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00884838116771), received between Jan 15, 2025 and Sep 28, 2026 — classified as 1 death, 3 injuries, 104 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (33 reports).

11 FDA recall records name this device's identifier, 11 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 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, 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 ↗

3. 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 ↗

4. Mar 19, 2026Class IIOpen, 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. 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-1678-2026 · Root cause: Device Design · Recall details · FDA record ↗

6. 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-1349-2026 · Root cause: Device Design · Recall details · FDA record ↗

7. 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 ↗

8. Dec 8, 2025Class IIOpen, 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 ↗

9. 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-1094-2025 · Root cause: Device Design · Recall details · FDA record ↗

10. Jan 13, 2025Class IOpen, Classified

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

    Z-1160-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• DeathAug 7, 2026Poor Quality Image

  It was initially reported to Philips by a hospital staff member that a patient passed away on (b)(6) 2026, and that poor image quality contributed to this outcome. Upon clinical follow-up, Philips has received additional information from the institution¿s Lab Manager stating that while a patient death did occur, it was not related to image quality. The Lab Manager also requested that the earlier statement provided be disregarded. An investigation into this complaint has been initiated by Philips.

  Patient problems: Insufficient Information

  MAUDE report 50174378 ↗
• InjuryJul 31, 2026Image Orientation Incorrect

  It was reported that after an ST-Elevation Myocardial Infarction (STEMI) patient was positioned on the table, prepped, sedated, and vascular access was obtained, fluoroscopy was initiated. At that time, the images were observed to be displayed in reverse ("backwards"). The user restarted the system; however, the issue persisted. The patient was subsequently transferred to another facility where the procedure was completed. The patient reportedly remained stable. An investigation into the reported event has been initiated by Philips.

  Patient problems: Insufficient Information; Ischemia

  MAUDE report 50097325 ↗
• InjuryMay 29, 2026Device Slipped

  IT WAS REPORTED TO PHILIPS THAT DURING TRANSFER FROM THE TABLE TO THE GURNEY, THE MATTRESS SLIPPED AND THE PATIENT FELL. THE REPORT INDICATED THAT AN INJURY OCCURRED; HOWEVER, NO FURTHER DETAILS REGARDING THE ALLEGED INJURY HAVE BEEN PROVIDED TO DATE. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

  Patient problems: Fall

  MAUDE report 25332341 ↗
• MalfunctionMay 28, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM WAS UNABLE TO PERFORM GEOMETRY 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 25316829 ↗
• MalfunctionMay 26, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOTSWITCH CHARGER WAS DAMAGED WHICH CAN IMPACT IMAGING. 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 25278678 ↗
• MalfunctionMay 22, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THERE WAS AN ERROR STATING GENERATOR WAS BUSY, WHICH CAN IMPACT THE 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 25254368 ↗
• MalfunctionMay 22, 2026Unintended System Motion

  IT WAS REPORTED TO PHILIPS THAT THE C-ARM WAS MOVING 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 25252585 ↗
• MalfunctionMay 15, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM GEOMETRY MOVEMENTS. 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 25180352 ↗
• MalfunctionMay 12, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM WAS UNABLE TO PERFORM GEOMETRY MOVEMENTS. 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 25148766 ↗
• MalfunctionMay 8, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE POWER BUTTON ON THE REVIEW MODULE IS STUCK, IMPACTING BOOT UP. 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 25122125 ↗
• MalfunctionMay 6, 2026

  DURING A TAVR [TRANSCATHETER AORTIC VALVE REPLACEMENT] PROCEDURE IMAGE QUALITY BEGAN DETERIORATING WITH THE C-ARM, THE IMAGE FLUORO FLAVOR ON SYSTEM HAD TO BE INCREASED IN ORDER TO CLEARLY SEE THE WIRES DURING THE PROCEDURE. DURING THE DEPLOYMENT OF THE VALVE, THE SYSTEM DISPLAYED AN ERROR INDICATING THE TUBE WAS OVERHEATING. WE IMMEDIATELY CONTACTED PHILIPS AND MADE THE REPORT, AND AN ENGINEER WAS DISPATCHED TO CHECK THE SYSTEM. 2,696 MGY WITH 29.7 MINUTES OF FLUORO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093778 ↗
• MalfunctionApr 30, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE IMAGE DETECTOR SHIFT ASSAY OF THE L-ARC WAS DEFECTIVE, WHICH CAN IMPACT GEOMETRY MOVEMENTS. 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 25042833 ↗
• MalfunctionApr 28, 2026Unintended System Motion

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM 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 25017975 ↗
• MalfunctionApr 23, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD STOPPED WORKING AS THE MOVEMENT WAS AFFECTED BY A FAILURE OF AN ARC MOTOR CONTROLLER. THE SYSTEM WAS INSIDE 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 24961789 ↗
• MalfunctionApr 22, 2026No Display/Image

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S MAIN SCREEN WAS NOT WORKING, WHICH CAN IMPACT THE IMAGING AND THE GEOMETRY MOVEMENT WAS ALSO NOT WORKING. 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 24949961 ↗
• MalfunctionApr 22, 2026Unintended System Motion

  IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM PERFORMED AN UNCOMMANDED MOVEMENT. 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 24949053 ↗
• MalfunctionApr 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO PHILIPS THAT THE COVER FALLS OFF WHEN MOVING MONITOR. 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 24939567 ↗
• MalfunctionMar 31, 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 24743929 ↗
• MalfunctionMar 25, 2026Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM WAS UNABLE TO PERFORM GEOMETRY MOVEMENTS. THE PATIENT WAS MOVED TO ANOTHER SYSTEM. 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 24687079 ↗
• MalfunctionMar 25, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PRODUCE 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 24685449 ↗
• MalfunctionMar 20, 2026Unintended System Motion

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM MOVED ON ITS OWN IN THE MIDDLE OF THE CASE. 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 24656386 ↗
• MalfunctionMar 17, 2026Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618104 ↗
• MalfunctionMar 9, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DID NOT BOOT UP WHEN POWERED ON. THREE BEEPS WERE HEARD DURING SYSTEM STARTUP, AND THE SYSTEM DID NOT PROCEED WITH THE NORMAL BOOT PROCESS. 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 24544233 ↗