Azurion Azurion 3 M15 (REF 722230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838116733), received between Mar 17, 2026 and Mar 17, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

7 FDA recall records name this device's identifier, 7 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. How this data works · Data updated Oct 13, 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 · 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 · 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 · FDA record ↗

4. 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 · 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-1345-2026 · Root cause: Device Design · 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 · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Activation Failure

  IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP PROPERLY. 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 24618100 ↗