Affiniti 70 Ultrasound System 795210Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838106611), received between May 12, 2025 and Jul 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (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. Oct 9, 2023Class IICompleted

   Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.

   Z-0284-2024 · Root cause: Software design · Recall details · FDA record ↗

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.

• MalfunctionJul 2, 2025Crack; Crack

  IT WAS REPORTED THAT THE INTRACAVITY C10-3V TRANSDUCER SEAL WAS CRACKED BETWEEN THE TWO HALVES OF THE TRANSDUCER, RESULTING IN CLEANING FLUID ENTERING AND CAUSING A GREEN SUBSTANCE AT THE BOTTOM OF THE TRANSDUCER CONNECTOR. THE TRANSDUCER WAS ASSOCIATED WITH THE AFFINITI 70 ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE, DURING CLEANING AND INSPECTION, AND THE TRANSDUCER WAS REMOVED FROM SERVICE. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE PHILIPS SERVICE ENGINEER REPLACED THE TRANSDUCER 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 22391635 ↗
• MalfunctionJun 18, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT AN AMETEK POWERVAR 3KVA UNINTERRUPTIBLE POWER SUPPLY (UPS) HAD OVERHEATED AND EMITTED AN ODOR. THE UPS HAD SWOLLEN INTERNAL BATTERIES WHICH SHOWED SIGNS OF LEAKAGE. THE UPS WAS USED WITH THE AFFINITI 70 ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. 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 22285526 ↗
• MalfunctionMay 12, 2025Incorrect Measurement; Incorrect Measurement

  A CUSTOMER REPORTED THAT WHEN PERFORMING EXAMS WITH THE C6-2 TRANSDUCER ON THEIR AFFINITI 70 ULTRASOUND SYSTEM AND GATHERING THE DOPPLER MEASUREMENT OF THE FETAL CALCULUS BETWEEN ONE WAVEFORM AND ANOTHER, THERE WAS AN EMPTY SPACE THAT THE DOCTOR CONSIDERED TO BE ZERO. THE CUSTOMER ALLEGES THIS HAS THE POTENTIAL TO LEAD TO A MISDIAGNOSIS. THE PATIENT DID NOT REQUIRE ANY LIFESAVING TREATMENT OR THERAPY OR HAVE A DECLINE IN THEIR STATE OF HEALTH. THE EXAM WAS COMPLETED USING ANOTHER SYSTEM. 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 22001989 ↗