Affiniti 70 Diagnostic Ultrasound SystemRecalls & reported problems across all models

We found 3 models of Affiniti 70 Diagnostic Ultrasound System by Philips Ultrasound LLC in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Apr 29, 2019 and Aug 6, 2026 — classified as 1 death, 3 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (18 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Affiniti 70 Diagnostic Ultrasound System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported Affiniti 70 Diagnostic Ultrasound System problems

Affiniti 70 Diagnostic Ultrasound System models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Affiniti 70 Diagnostic Ultrasound System 989605416151

  System, imaging, pulsed doppler, ultrasonic
  1 recall1 death47 reports
• Affiniti 70 Diagnostic Ultrasound System 795210

  System, imaging, pulsed doppler, ultrasonic
  1 recall4 reports
• Affiniti 70 Diagnostic Ultrasound System 795210

  System, Imaging, Pulsed Doppler, Ultrasonic
  2 reports

Recent Affiniti 70 Diagnostic Ultrasound System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50163479 ↗
• InjuryMay 13, 2026Mechanical Jam; Insufficient Device Problem Information

  IT WAS REPORTED THE USER OF THE AFFINITI 70 ULTRASOUND SYSTEM BROKE THE SPLEEN WHEN LIFTING AND MOVING THE SYSTEM. NO FURTHER INFORMATION WAS RECEIVED. THIS EVENT WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION. THERE IS AN ALLEGATION OF INJURY TO A SPLEEN, HOWEVER THERE IS INSUFFICIENT INFORMATION REGARDING THE USER OUTCOME AT THIS TIME. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 25162226 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 1, 2026Fracture

  A CUSTOMER REPORTED THEIR C10-3V TRANSDUCER HAD A HOLE IN THE LENS. THIS PROBE IS ASSOCIATED WITH THE AFFINITI 70 ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM. 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 24757879 ↗
• MalfunctionMar 30, 2026Electrical Overstress

  IT WAS REPORTED THE AFFINITI 70 ULTRASOUND SYSTEM¿S POWER CABLE HAD MELTED MATERIAL ON A PRONG OF THE CONNECTOR. THE POWER CABLE WAS CONNECTED TO A UPS (UNINTERRUPTIBLE POWER SUPPLY). THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE POWER CABLE WAS REPLACED 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 24713171 ↗
• 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 ↗
• InjuryFeb 17, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE AFFINITI 70 ULTRASOUND SYSTEM¿S IMAGE DISPLAY WAS INCOMPLETE DURING AN UNSPECIFIED PROCEDURE, WHICH RESULTED IN A MISDIAGNOSIS. ADDITIONAL INFORMATION IS BEING OBTAINED TO DETERMINE PATIENT OUTCOME. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 24366628 ↗
• MalfunctionDec 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRACAVITY MODEL 3D9-3V TRANSDUCER WAS LEAKING FLUID FROM THE TIP OF THE PROBE DOME. THE PROBE WAS ASSOCIATED WITH THE AFFINITI 70 ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. IN RESPONSE TO THE ISSUE, THE CUSTOMER RECEIVED A REPLACEMENT TRANSDUCER. THE BIOMED CONFIRMED THAT THE NEW REPLACEMENT TRANSACTION IS WORKING TO FACTORY SPECIFICATIONS AND THE ULTRASOUND SYSTEM IS BACK IN CLINICAL USE. 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 23853261 ↗
• MalfunctionDec 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD DAMAGE TO THE LENS WITH EXPOSED CIRCUITRY. THIS WAS ASSOCIATED WITH AN AFFINITI 70 ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM. 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 23730388 ↗
• MalfunctionOct 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT AN C10-3V TRANSDUCER HAD FAILED THE ELECTRICAL SAFETY TEST AND WAS ASSOCIATED WITH THE AFFINITI 70 ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. IT IS UNKNOWN IF THE ISSUE OCCURRED DURING CLINICAL USE. 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 23378125 ↗
• MalfunctionAug 14, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT AN C10-3V TRANSDUCER HAD FAILED THE ELECTRICAL SAFETY TEST AND HAD LENS DAMAGE. THIS TRANSDUCER WAS ASSOCIATED WITH THE AFFINITI 70 ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS FOUND WHILE OUTSIDE OF CLINICAL USE. 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 22804409 ↗
• 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 ↗
• MalfunctionMay 29, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE SWIVEL MECHANISM OF THE AFFINITI 70 ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. 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 22107601 ↗

Other Philips Ultrasound LLC products

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• Transducer X5-13 models · 0 reports · 10 recalls
• EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM5 models · 330 reports · 3 recalls
• Transducer C10-3v2 models · 0 reports · 7 recalls
• Transducer X7-2t4 models · 26 reports · 6 recalls
• Transducer C5-210 models · 0 reports · 6 recalls
• Transducer S5-12 models · 0 reports · 6 recalls