Affiniti 70 Diagnostic Ultrasound System 795210 (UDI 00884838114180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838114180), received between Feb 20, 2026 and Apr 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Mechanical Jam

  IT WAS REPORTED THE S7-3T TRANSDUCER WAS NOT ARTICULATING PROPERLY DURING USE. THE TRANSDUCER WAS ASSOCIATED WITH AN AFFINITI 70 ULTRASOUND SYSTEM. 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 24789880 ↗
• MalfunctionFeb 20, 2026Patient Data Problem

  IT WAS REPORTED THAT, DURING AN ULTRASOUND EXAMINATION ON THE AFFINITI 70 ULTRASOUND SYSTEM, THE PREVIOUS PATIENT REPORT APPEARED ON THE LATEST PATIENT DATA. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER A SYSTEM REBOOT. 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 24405806 ↗