inforMED
MalfunctionIYN

CX50

Received Jul 17, 2026 · Event occurred Jun 30, 2026

Report 3019216-2026-100277 · MDR key 25850798

Device

Generic name

System, Imaging, Pulsed Doppler, Ultrasonic

Catalog number

795087

Product problems

  • Poor Quality Image

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE CX50 ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. THE SYSTEM HAD IMAGE QUALITY DEGRADATION DURING AN UNSPECIFIED HAND-GUIDED PROCEDURE AND REQUIRED MULTIPLE RESTARTS TO RESOLVE. THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER INSPECTED THE SYSTEM BASED ON THE REPORTED PROBLEM, CONFIRMED THE PROBLEM, AND REPLACED THE EBOX TO ADDRESS THE CUSTOMER'S IMMEDIATE CONCERNS.PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW-UP REPORT WILL BE SUBMITTED.