Affiniti 30 Diagnostic Ultrasound System 989605457591Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884838074187), received between Oct 14, 2020 and Sep 30, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950965 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THE C9-4V TRANSDUCER HAD SEPARATION OF THE HEAD FROM THE BODY OF THE TRANSDUCER. THIS WAS ASSOCIATED WITH AN AFFINITI 30 ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THERE WAS NO FURTHER INFORMATION AVAILABLE. 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 23573137 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS DAMAGE TO THE MEMBRANE OF AN INTRACAVITY TRANSDUCER, EXPOSING THE METAL UNDERNEATH THE MEMBRANE, RESULTING IN A FAILED LEAKAGE CURRENT TEST. THE C9-4V TRANSDUCER WAS ASSOCIATED WITH THE AFFINITI 30 ULTRASOUND SYSTEM AT THE CUSTOMER'S SITE. THE ISSUE WAS DISCOVERED WHILE THE DEVICE WAS OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER EVALUATED THE TRANSDUCER AND CONFIRMED THE MEMBRANE WAS DAMAGED. THE TRANSDUCER 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 21721584 ↗
• MalfunctionJun 18, 2024Poor Quality Image; Poor Quality Image

  AN NMPA REPORT 1335143062024000113 WAS RECEIVED AND REPORTED A MISDIAGNOSIS, MISJUDGMENT, AND UNABLE TO RECEIVE TIMELY TREATMENT TO A PATIENT. THE AFFINITI 30 ULTRASOUND SYSTEM WAS BEING USED FOR AN UNSPECIFIED PATIENT EXAMINATION. THE 2D GAIN OF THE SYSTEM COULD NOT BE ADJUSTED, RESULTING IN IMAGE DISTORTION, AND AFFECTING THE DIAGNOSIS OF THE PATIENT. THERE WAS NO REPORTED PATIENT OR USER HARM AS A RESULT OF THIS ISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME; ATTEMPTS TO GATHER MORE DETAILS ARE UNDERWAY. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT. IF FURTHER INFORMATION BECOMES AVAILABLE OR UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557955 ↗
• MalfunctionSep 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THE MONITOR ARM DETACHED FROM THE ARTICULATION ARM ASSEMBLY OF THEIR AFFINITI 30 ULTRASOUND SYSTEM. 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 17685904 ↗
• MalfunctionMar 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THE MONITOR FELL FROM THEIR AFFINITI 30 ULTRASOUND SYSTEM WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE MONITOR WIRES PREVENTED THE MONITOR FROM COMPLETELY DETACHING FROM THE SYSTEM. A PHILIPS SERVICE ENGINEER INSTALLED A NEW TILT SWIVEL ARM KIT TO REPAIR THE SYSTEM. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE SYSTEM HAS BEEN RETURNED TO SERVICE WITH NO ADDITIONAL ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690895 ↗
• MalfunctionMay 13, 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. THE ULTRASOUND SYSTEM HAS BEEN RETURNED TO SERVICE WITH NO ADDITIONAL ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821868 ↗
• MalfunctionApr 14, 2021Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR AFFINITI 30 ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT LOCK INTO POSITION. IT IS UNKNOWN IF THE INCIDENT OCCURRED WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE CONTROL PANEL CABLES WERE ADJUSTED TO REPAIR THE SYSTEM. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665892 ↗
• MalfunctionOct 14, 2020Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED AN INCIDENT WHERE THE SWIVEL MECHANISM OF THEIR AFFINITI ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT FUNCTION PROPERLY. IT COULD NOT BE DETERMINED IF THE PROBLEM WAS IDENTIFIED WHILE THE SYSTEM WAS STATIONARY OR IN TRANSIT. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10680974 ↗