inforMED
MalfunctionOWB

Azurion

Received Jul 31, 2026 · Event occurred Jul 8, 2026

Report 3042175844-2026-001973 · MDR key 50095608

Device

Generic name

Interventional Fluoroscopic X-ray System

Model number

Azurion 3 M15

Catalog number

722222

Product problems

  • Radiation Output Failure

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

It was reported to Philips that the system was unable to produce X-rays.The device was in clinical use during this issue occurrence. No harm to user or patient was reported to Philips.Philips has started an investigation of this complaint.