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CX50 DIAGNOSTIC ULTRASOUND SYSTEM 795087Recalls & reported problems

Philips Ultrasound LLC · Class 2

All models of CX50 Diagnostic Ultrasound System (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838097964), received between Feb 1, 2021 and Oct 28, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Application Program Freezes or Fails to Launch1
  • Electrical /Electronic Property Problem1
  • Failure to Power Up1
  • Material Integrity Problem1
  • Patient Data Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 28, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

    IT WAS REPORTED THE CX50 ULTRASOUND SYSTEM WAS NOT AVAILABLE FOR AN EMERGENCY SURGERY. IT WAS DISCOVERED THAT THE ULTRASOUND SYSTEM WAS UNABLE TO TURN ON DURING SET-UP. A PHILIPS FIELD SERVICE ENGINEER SECURED THE POWER SUPPLY CONNECTOR TO RESOLVE THE CUSTOMER¿S IMMEDIATE CONCERNS. THERE WAS NO REPORTED PATIENT NOR USER HARM 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 23408135 ↗
  • MalfunctionSep 19, 2025Electrical /Electronic Property Problem; Material Integrity Problem; Electrical /Electronic Property Problem; Material Integrity Problem

    A CUSTOMER REPORTED THEIR INTRACAVITY C10-3V TRANSDUCER HAD A PIN HOLE ON THE LENS, RESULTING IN UNSTABLE ELECTRICAL SAFETY TEST READINGS. THE TRANSDUCER WAS ASSOCIATED WITH THE CX50 ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE REPORTED DAMAGE AND TESTS WERE IDENTIFIED OUTSIDE OF CLINICAL USE. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE PHILIPS 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 23093081 ↗
  • MalfunctionJan 26, 2023Patient Data Problem; Patient Data Problem

    THE CUSTOMER REPORTED THAT INTERMITTENTLY, WHEN TRANSFERRING THE STUDY FROM THEIR CX50 TO A PEN DRIVE (USB), WHEN THE STUDY IS UPLOADED AND PRINTED FROM A COMPUTER, THE REPORT SHOWS TWO PATIENT NAMES. WHEN THEY RESTART THE MACHINE IT ISSUE IS RESOLVED. ALSO, WHEN THE REPORT IS PRINTED DIRECTLY FROM THE CX50, THE HEADER AND PATIENT NAME ARE CORRECT. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16246911 ↗
  • MalfunctionFeb 1, 2021Failure to Power Up; Failure to Power Up

    A CUSTOMER REPORTED THEIR CX50 ULTRASOUND SYSTEM WOULD NOT POWER UP TO PERFORM TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING AT THE END OF A CARDIAC PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH NO HARM OR IMPACT TO THE PATIENT¿S OUTCOME.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11257800 ↗

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Sources and updates

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