Affiniti 70 Diagnostic Ultrasound System 989605416151Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00884838056251), received between Apr 29, 2019 and Aug 6, 2026 — classified as 1 death, 3 injuries, 43 malfunctions.

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

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 25 most recent of 47 reports, 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 19, 2025Crack; Crack

  IT WAS REPORTED THE INTRACAVITY 3D9-3V TRANSDUCER HAD A CRACK IN THE LENS MEMBRANE AND WAS LEAKING OIL. THE TRANSDUCER WAS ASSOCIATED WITH THE AFFINITI 70 ULTRASOUND SYSTEM. THIS ISSUE OCCURRED OUTSIDE OF PATIENT USE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. A REMOTE SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE WITH THE CUSTOMER AND SHIPPED A REPLACEMENT 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 22043793 ↗
• MalfunctionApr 21, 2025Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR 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. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871743 ↗
• MalfunctionSep 11, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED 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. THE PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM AND DETERMINED THE CONTROL PANEL ARTICULATION ARM ASSEMBLY ALONG WITH THE DETENT CABLE RELEASE AND STRUT RELEASE CABLE REQUIRED REPLACEMENT TO REPAIR THE 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 20190973 ↗
• InjuryMay 9, 2024Poor Quality Image; Poor Quality Image

  A MISDIAGNOSIS WAS REPORTED WHEN USING THE AFFINITI 70 ULTRASOUND SYSTEM AND AN X5-1 TRANSDUCER. THE SYSTEM DID NOT PRODUCE QUALITY COLOR AND SPECTRAL DOPPLER SIGNAL WHEN PERFORMING A CARDIAC ULTRASOUND. A PATIENT HAD A PRIOR ECHO IN WHICH THE AORTIC STENOSIS GRADIENT WAS FOUND TO BE MODERATE-SEVERE INSTEAD OF MILD-MODERATE. THE MILD REGURGITANT JET WAS NEARLY IMPOSSIBLE TO SEE. THE PATIENT'S OUTCOME WAS AFFECTED DUE TO A CHANGE OF MEDICATION AND FURTHER TESTING TO CLASSIFY THE SEVERITY OF THE AORTIC STENOSIS. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

  Patient problems: Insufficient Information

  MAUDE report 19277778 ↗
• MalfunctionNov 22, 2023Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED WHEN USING THE AFFINITI 70 ULTRASOUND SYSTEM THE ACQUIRED IMAGES WERE BEING SAVED IN THE PREVIOUS PATIENT¿S EXAM. THE USER THEN RESTARTED THE EXAM WITH NO FURTHER COMPLAINT. THE PHILIPS¿ SERVICE ENGINEER REINSTALLED THE SOFTWARE WHICH WAS FOUND TO BE DAMAGED. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192539 ↗
• MalfunctionSep 1, 2023Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED THAT THE AFFINITI 70 ULTRASOUND SYSTEM CONTROL PANEL WAS SWIVELING DURING TRANSPORT WITHIN THE CUSTOMER SITE. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE TO EVALUATE THE SYSTEM AND WAS ABLE TO ADJUST THE CABLE AND STRUT RELEASE TENSION TO RESOLVE THE CUSTOMER'S ISSUE. THE SYSTEM HAS BEEN RETURNED TO SERVICE WITH NO ADDITIONAL ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671134 ↗
• MalfunctionAug 30, 2023Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE BASE WILL NOT LOCK ON THEIR AFFINITI 70 ULTRASOUND SYSTEM. IT IS UNKNOWN IF THE SYSTEM WAS STATIONERY OR BEING TRANSPORTED AT THE TIME THIS ISSUE OCCURRED. THE FAILURE OCCURRED WHILE IN CLINICAL USE. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652145 ↗
• MalfunctionApr 7, 2023Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE TOWER WHERE THE KEYBOARD SITS WILL NOT LOCK ON THEIR AFFINITI 70 ULTRASOUND SYSTEM. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701751 ↗
• MalfunctionFeb 13, 2023Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THAT THEIR AFFINITI 70 ULTRASOUND SYSTEM'S ARTICULATION ARM WAS NOT LOCKING IN PLACE. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16365382 ↗
• MalfunctionJan 27, 2023Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR AFFINITI 70 ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT LOCK INTO POSITION PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252958 ↗
• MalfunctionJan 19, 2023Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE CONTROL PANEL ARM WILL NOT STAY LOCKED IN PLACE ON THEIR AFFINIT 70 ULTRASOUND SYSTEM. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16209819 ↗
• MalfunctionNov 30, 2022Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED DISLODGED RIGHT SIDE OF ENCLOSURE TRIGGER ON THEIR AFFINITI 70 ULTRASOUND SYSTEM. THERE WAS NO INDICATION OR HARM TO USER OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886848 ↗
• MalfunctionMar 24, 2022Unintended System Motion; Device Dislodged or Dislocated; Unintended System Motion; Device Dislodged or Dislocated

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR AFFINITI 70 ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT REMAIN IN A LOCKED POSITION. IT IS UNKNOWN IF THE SYSTEM WAS BEING TRANSPORTED WITHIN THE USER FACILITY WHEN THIS ISSUE WAS DISCOVERED. THE CONTROL PANEL ARTICULATION ARM ASSEMBLY WAS REPLACED TO REPAIR THE SYSTEM. NO PATIENT OR USER WAS REPORTED TO BE HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13874890 ↗
• MalfunctionAug 12, 2021Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED AN INCIDENT WHERE THE SWIVEL MECHANISM OF THEIR AFFINITI ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT LOCK INTO POSITION WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312761 ↗
• MalfunctionAug 3, 2021Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED TWO EXAMS WERE PERFORMED UNDER THE SAME PATIENT NAME. THE CUSTOMER WAS INSTRUCTED ON HOW TO APPEND AND SEPARATE THE EXAMS TO RESOLVE THE IMMEDIATE ISSUE. 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 12271120 ↗