Affiniti 30 Ultrasound System 795218Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838106628), received between Apr 2, 2025 and Apr 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Structural Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THERE WAS BREAKAGE OF THE MONITOR ARM OF THE AFFINITI 30 ULTRASOUND SYSTEM DURING TRUCK TRANSPORT. PHILIPS FIELD SERVICE ENGINEER REPLACED THE MONITOR ARM TO RESOLVE THE CUSTOMER¿S IMMEDIATE CONCERNS. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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 21758679 ↗