Azurion Azurion 5 M12 (REF 722231)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884838116740), received between Dec 31, 2024 and Apr 30, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 reports).

8 FDA recall records name this device's identifier, 8 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. 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 ↗

5. 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 ↗

6. 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 ↗

7. 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 ↗

8. 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 ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PRODUCE X-RAYS. THERE WAS NO HARM REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25041134 ↗
• MalfunctionApr 15, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT. THE SYSTEM WAS OUTSIDE OF 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 24887030 ↗
• MalfunctionMar 24, 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 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 24673592 ↗
• MalfunctionMar 13, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT TO THE CLINICAL APPLICATION. NO HARM WAS REPORTED TO PHILIPS. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF REPORTED EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592433 ↗
• MalfunctionJun 30, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS INTERMITTENTLY GIVING A COMMUNICATION ERROR DURING BOOT, WHICH CAN IMPACT BOOTING. NO HARM WAS REPORTED TO PHILIPS. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358281 ↗
• MalfunctionMay 15, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THERE WAS AN ISSUE WITH THE SYSTEM'S COLLIMATOR, WHICH COULD 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 22025327 ↗
• MalfunctionMar 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE GEOMETRY MOVEMENTS WERE UNAVAILABLE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE 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 21522096 ↗
• MalfunctionDec 31, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED TO PHILIPS THAT THE GEOMETRY MOVEMENTS WERE UNAVAILABLE. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048210 ↗