Affiniti 70 Diagnostic Ultrasound System 795210 (UDI 00884838097766)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838097766), received between Jul 21, 2022 and Apr 17, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 6, 2021Class IICompleted

   Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

   Z-2484-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT A CRITICAL PROCEDURE COULD NOT BE COMPLETED ON THE AFFINITI 70 ULTRASOUND SYSTEM. THE SYSTEM DISPLAYED AN ERROR MESSAGE DURING AN ARTERIAL LINE INSERTION PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER INITIATED THE REPAIR PROCESS TO ADDRESS THE CUSTOMER¿S IMMEDIATE CONCERN. PHILIPS HAS STARTED AN INVESTIGATION, AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913441 ↗
• MalfunctionApr 10, 2026Poor Quality Image

  IT WAS REPORTED THAT A CRITICAL CARDIAC PROCEDURE WITH THE X7-2T TRANSDUCER COULD NOT BE COMPLETED ON THE AFFINITI 70 ULTRASOUND SYSTEM DUE TO IMAGE ARTIFACT. THE PROCEDURE WAS ABLE TO BE COMPLETED ON ANOTHER ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER CLEANED THE CONNECTORS ON THE SYSTEM PORTS AND TRANSDUCER TO ADDRESS THE CUSTOMER¿S IMMEDIATE CONCERN. 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 24841763 ↗
• MalfunctionJul 3, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE INTRACAVITY C10-3V TRANSDUCER FAILED ELECTRICAL SAFETY TESTING. THE TRANSDUCER WAS ASSOCIATED WITH THE AFFINITI 70 ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE PHILIPS SERVICE ENGINEER CONFIRMED THERE WAS NO PHYSICAL DAMAGE TO THE TRANSDUCER. THE TRANSDUCER WAS REPLACED TO RESOLVE 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 22396342 ↗
• MalfunctionJul 21, 2022Incorrect Measurement; Incorrect Measurement

  A CUSTOMER REPORTED THEIR AFFINITI 70 ULTRASOUND SYSTEM HAD PRODUCED INCORRECT VOLUME CALCULATIONS DURING A PROSTATE EXAM DUE TO AN INCORRECT VOLUME CALCULATION ENTRY WHEN COMPOSING A CUSTOM PRESET MANUALLY. THE ISSUE WAS OBVIOUS TO THE USER AND THERE WAS NO HARM TO THE USER OR PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15079643 ↗