AFFINITI 50 DIAGNOSTIC ULTRASOUND SYSTEM 795208 (UDI 00884838097759)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884838097759), received between Jun 1, 2021 and Apr 9, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2025Material Fragmentation; Material Fragmentation

  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 TIP OF THEIR C9-4V TRANSDUCER HAS BROKEN OFF. 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. THE SERVICE ENGINEER REPLACED THE TRANSDUCER 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 21804941 ↗
• MalfunctionJan 31, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE AFFINITI 50 ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE SYSTEM 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 EVALUATED THE SYSTEM AND VERIFIED THE REPORTED 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 21284056 ↗
• MalfunctionJul 20, 2023Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED THE CONTROL PANEL DOES NOT LOCK IN PLACE ON THEIR AFFINITI 50 ULTRASOUND SYSTEM 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362165 ↗
• MalfunctionAug 5, 2021Mechanical Jam; Mechanical Jam

  A CUSTOMER REPORTED A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) TRANSDUCER WOULD NOT ARTICULATE DOWNWARD ON AN AFFINITI 50 ULTRASOUND SYSTEM DURING USE. SERVICE FOR THE REPLACEMENT OF THE SUSPECT TRANSDUCER IS IN PROGRESS. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283147 ↗
• MalfunctionAug 3, 2021Mechanical Jam; Mechanical Jam

  A CUSTOMER REPORTED THERE WAS NO ARTICULATION MOVEMENT FROM THE HANDLE OF AN X7-2T TRANSDUCER ON AN AFFINITI 50 ULTRASOUND SYSTEM DURING USE. A PHILIPS FIELD SERVICE ENGINEER INSPECTED THE SYSTEM AND CONFIRMED THE TRANSDUCER WOULD NOT ARTICULATE IN ONE DIRECTION. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271434 ↗
• MalfunctionJun 1, 2021Structural Problem; Structural Problem

  A CUSTOMER REPORTED AN AFFINITI 50 ULTRASOUND SYSTEM¿S CONTROL PANEL ARTICULATION ARM ASSEMBLY BROKE AT THE SYSTEM ATTACHMENT POINT. THE CONTROL PANEL DID NOT FALL, AND NO USER OR PATIENT WAS INJURED AS A RESULT OF THIS EVENT. THE CONTROL PANEL WAS REPLACED TO RESOLVE THE IMMEDIATE ISSUE. THE SYSTEM WAS PLACED BACK INTO SERVICE WITH NO ADDITIONAL ISSUES REPORTED POST REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913878 ↗