Affiniti 50 Ultrasound System 795208Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838106604), received between Apr 17, 2025 and Jan 29, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Detachment of Device or Device Component

  A CUSTOMER REPORTED THE MONITOR ARM OF AN AFFINITI 50 ULTRASOUND SYSTEM WAS DAMAGED DURING TRANSPORT WITHIN THE USER FACILITY. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THIS ISSUE WAS DISCOVERED OUTSIDE CLINICAL USE. THE CUSTOMER WAS PROVIDED A QUOTE FOR A REPLACEMENT MONITOR ARM. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207806 ↗
• MalfunctionSep 9, 2025Material Integrity Problem; Material Integrity Problem

  A CUSTOMER REPORTED THEIR 3D9-3V TRANSDUCER WAS LEAKING FLUID. THIS PROBE IS ASSOCIATED WITH THE AFFINITI 50 ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF PATIENT USE, AND THERE WAS NO PATIENT OR USER HARM. THE REMOTE SERVICE ENGINEER CONFIRMED THE REPORTED PROBLEM THROUGH COMMUNICATION WITH THE SONOGRAPHER. THE TRANSDUCER REPLACEMENT WAS SHIPPED DIRECTLY TO THE CUSTOMER TO ADDRESS THE CUSTOMER¿S IMMEDIATE CONCERNS. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006461 ↗
• MalfunctionApr 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS PART OF CAPA 5677695, IT WAS IDENTIFIED THAT RETROSPECTIVE REVIEW ACTIVITIES WERE WARRANTED FOR INTRACAVITY TRANSDUCER DAMAGE IF PHYSICALLY SPLIT, FRACTURED, OR CONTAINS SHARP EDGES ON THE TRANSDUCER, REGARDLESS OF WHETHER THE DEVICE IS IN CLINICAL USE. PHILIPS ULTRASOUND IS REPORTING THIS COMPLAINT AS PART OF THE RETROSPECTIVE REVIEW COMPLETED FOR INTRACAVITY TRANSDUCER DAMAGE. IT WAS REPORTED THE X7-2T TRANSDUCER HAD A TEAR AND OIL SEEPING. THIS TRANSDUCER WAS ASSOCIATED WITH AN AFFINITI 50 ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION WAS AVAILABLE. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860887 ↗