Affiniti 50 Diagnostic Ultrasound System 989605410251Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00884838056244), received between Mar 3, 2017 and Aug 31, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532151 ↗
• MalfunctionDec 18, 2025Fracture; Fracture

  IT WAS REPORTED THE AFFINITI 50 ULTRASOUND SYSTEM'S MONITOR BRACKET BROKE AND CAUSED A MONITOR DETACHMENT. THE ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED. A REPLACEMENT ARTICULATION ARM WAS SHIPPED DIRECTLY TO THE CUSTOMER TO ADDRESS THEIR 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 23839461 ↗
• MalfunctionOct 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED AN AFFINITI 50 ULTRASOUND SYSTEM¿S MONITOR, DURING CLINICAL USE FELL OFF WITHOUT DETACHING AS THE ARTICULATING ARM BROKE IN HALF. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE FIELD SERVICE ENGINEER REPLACED THE ARTICULATING MONITOR ARM TO RESOLVE 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 23438982 ↗
• MalfunctionSep 19, 2025No Tactile Prompts/Feedback; No Tactile Prompts/Feedback

  IT WAS REPORTED THAT A BREAST MASS BIOPSY COULD NOT BE COMPLETED ON THE AFFINITI 50 ULTRASOUND SYSTEM DUE TO A TOUCHSCREEN FAILURE. THE BIOPSY WAS ABLE TO BE COMPLETED AFTER THE SYSTEM WAS EXCHANGED. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS 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 23093012 ↗
• MalfunctionSep 15, 2025Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR AFFINITI 50 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. A PHILIPS SERVICE ENGINEER RESOLVED THE ISSUE BY REPLACING THE CABLE. THE SYSTEM HAS BEEN RETURNED TO USE. NO FURTHER ISSUES REPORTED. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051672 ↗
• MalfunctionJul 31, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE AFFINITI ULTRASOUND SYSTEM SHUTDOWN DURING A PATIENT EXAMINATION AND WAS ACCOMPANIED BY A BURNING SMELL AND SOME SMOKE WAS EMITTED. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. AFTER A FEW MINUTES, NO FURTHER SMOKE WAS OBSERVED, AND THE DEVICE WAS REMOVED FROM SERVICE. 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 22682764 ↗
• MalfunctionJun 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THE DISPLAY MONITOR MOUNTING BRACKET ON THEIR AFFINITI 50 ULTRASOUND SYSTEM BROKE CAUSING THE MONITOR TO FALL FORWARD ONTO THE CONTROL PANEL. THE ISSUE OCCURRED OUTSIDE OF USE, NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A REPLACEMENT TILT SWIVEL MONITOR ARM KIT HAS BEEN ORDERED 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 22120900 ↗
• MalfunctionApr 9, 2025Material Separation; Material Separation

  AS PART OF CAPA 5677695, IT WAS IDENTIFIED THAT RETROSPECTIVE REVIEW ACTIVITIES WERE WARRANTED FOR INTRACAVITY TRANSDUCER DAMAGE IF PHYSICALLY SPLIT, FRACTURED, OR CONTAINS SHARP EDGES ON THE TRANSDUCER, REGARDLESS OF WHETHER THE DEVICE IS IN CLINICAL USE. PHILIPS ULTRASOUND IS REPORTING THIS COMPLAINT AS PART OF THE RETROSPECTIVE REVIEW COMPLETED FOR INTRACAVITY TRANSDUCER DAMAGE. IT WAS REPORTED THE C9 4V TRANSDUCER HEAD WAS SEPARATING FROM THE BODY. THIS TRANSDUCER WAS ASSOCIATED WITH AN AFFINITI 50 ULTRASOUND SYSTEM. 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 21805210 ↗
• MalfunctionDec 30, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR AFFINITI 50 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. THE 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 21037158 ↗
• MalfunctionOct 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THE DISPLAY MONITOR MOUNTING BRACKET BROKE ON THEIR AFFINITI 50 ULTRASOUND SYSTEM. THE SITE¿S BIOMEDICAL DEPARTMENT ORDERED A REPLACEMENT TILT SWIVEL ARM BRACKET 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 20527850 ↗
• MalfunctionOct 11, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THE AFFINITI 50 ULTRASOUND SYSTEM¿S BATTERY HAD A BREACH IN THE PROTECTIVE CASE AND TRACES OF BURN MARKS ON THE POWER SUPPLY. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS 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 20431877 ↗
• MalfunctionJan 23, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE AFFINITI 50 ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. THE SYSTEM FROZE WITH AN ERROR CODE DURING PATIENT USE AND THE ECHOCARDIOGRAM WAS NOT ABLE TO BE COMPLETED. THERE WAS NO PATIENT OR USER HARM BECAUSE OF THIS EVENT. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18564296 ↗
• MalfunctionSep 15, 2023Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT DURING SURGERY, THE AFFINITI ULTRASOUND SYSTEM SUDDENLY TURNED OFF AUTOMATICALLY. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. MULTIPLE ATTEMPTS FOR INFORMATION REGARDING THE CASE DETAILS OR TO OBTAIN SYSTEM LOGS FOR INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER IS SUBMITTING A COMPLETE REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THE REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761032 ↗
• MalfunctionJul 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO PHILIPS THAT THEIR 3D9-3V C9-4V VAGINAL TRANSDUCER BROKE WHILE IN USE DURING A PATIENT EXAM. THERE WAS NO REPORT OF HARM ASSOCIATED WITH THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17363099 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  INITIALLY THIS EVENT WAS THOUGHT TO BE A CONTROL PANEL SWIVEL UNLOCKING. IT WAS LATER DETERMINED TO BE A MONITOR ARM DETACHMENT. IT WAS REPORTED THE AFFINITI 50 ULTRASOUND SYSTEM HAD A BROKEN AND DETACHED MONITOR ARM. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME AND NO PERSON WAS HARMED. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE MONITOR ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744689 ↗
• MalfunctionMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE AFFINITI ULTRASOUND SYSTEM¿S MONITOR ARM WAS DEFECTIVE. IT IS UNKNOWN AT THIS TIME IF THE MONITOR ARM DETACHED OR IF IT HAD A LOCKING ISSUE DURING TRANSPORT WITHIN THE SITE. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE FIELD SERVICE ENGINEER WILL BE DISPATCHED TO THE SITE TO EVALUATE THE MONITOR AND DETERMINE THE ROOT CAUSE OF THE ISSUE WHICH WILL BE INCLUDED IN A FOLLOW UP REPORT UPON EVALUATION COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544587 ↗
• MalfunctionFeb 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE ARTICULATING ARM IS UNABLE TO BE LOCKED ON THEIR AFFINITI 50 ULTRASOUND SYSTEM. IT IS UNKNOWN AT THIS TIME IF THE SYSTEM WAS MOBILE WHEN FAILURE OCCURRED. THERE IS NO DEATH OR SERIOUS INJURY WAS REPORTED. PHILIPS HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION TO NO AVAIL. IF FURTHER INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397918 ↗
• MalfunctionJul 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THE MONITOR ARM BRACKET BROKE OFF OF THEIR AFFINITI 50 ULTRASOUND SYSTEM. A PHILIPS SERVICE ENGINEER REPLACED THE TILT SWIVEL ARM AND TOUCHSCREEN 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 15130387 ↗
• MalfunctionMar 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THE MONITOR ARM BRACKET BROKE OFF OF THEIR AFFINITI 50 ULTRASOUND SYSTEM WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. A PHILIPS SERVICE ENGINEER ORDERED A REPLACEMENT TILT SWIVEL ARM THAT WAS INSTALLED BY THE CUSTOMER BIOMEDICAL DEPARTMENT 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 13827140 ↗
• MalfunctionJun 8, 2021Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE A PATIENT¿S DATA WAS MIXED WITH ANOTHER EXAM. ACCORDING TO THE CASE DETAILS, IMAGES FROM A PREVIOUS STUDY APPEARED IN THE NEXT PATIENT¿S EXAM. THE DATA MIX-UP WAS IDENTIFIED BY THE USER AND THERE WAS NO ALLEGATION OF ALTERED PATIENT OUTCOME AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963249 ↗
• MalfunctionMar 15, 2021Electrical Overstress; Electrical Overstress

  A CUSTOMER REPORTED THEIR AFFINITI ULTRASOUND SYSTEM¿S POWER CABLE PRODUCED A SMALL FLAME WHILE IN USE. THERE WAS NO INJURY OR PROPERTY DAMAGE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11489918 ↗
• MalfunctionFeb 5, 2021Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED AFTER SENDING A STUDY TO PACS FROM THEIR AFFINITI 50 ULTRASOUND SYSTEM, IT HAD SUBSEQUENTLY MERGED WITH ANOTHER PATIENT¿S STUDY. THE ISSUE WAS IDENTIFIED BY THE USER AND THERE WAS NO ALLEGATION OF ALTERED PATIENT OUTCOME AS A RESULT OF THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11286829 ↗
• MalfunctionFeb 3, 2021Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE THEIR AFFINITI 50 ULTRASOUND SYSTEM INCLUDED PREVIOUS PATIENT DATA ON THE NEXT PATIENT¿S REPORT. THE DATA MIX-UP WAS IDENTIFIED BY THE USER AND THERE WAS NO ALLEGATION OF ALTERED PATIENT OUTCOME AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11276070 ↗
• MalfunctionDec 10, 2020Device Fell; Device Fell

  A CUSTOMER REPORTED THE MONITOR ARM DETACHED FROM THEIR AFFINITI 50 ULTRASOUND SYSTEM WHILE MOVING THE UNIT WITHIN THE USER FACILITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT. THE SYSTEM REMAINS AT THE SITE AND WAS RETURNED TO SERVICE FOLLOWING THE REPLACEMENT OF THE MONITOR ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10988083 ↗
• MalfunctionNov 8, 2019Patient Data Problem

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE A PATIENT¿S DATA WAS MIXED WITH ANOTHER EXAM. ACCORDING TO THE FEEDBACK DETAILS, AN IMAGE FROM A PREVIOUS STUDY APPEARED IN THE NEXT PATIENT¿S EXAM. THE DATA MIX-UP WAS IDENTIFIED BY THE USER AND THERE WAS NO ALLEGATION OF ALTERED PATIENT OUTCOME AS A RESULT OF THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9297261 ↗