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EPIQ CVX Diamond Select 795122Recalls & reported problems

Philips Ultrasound LLC · 9.0 and 9.0.x · Class 2

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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838107472), received between Apr 3, 2025 and Apr 3, 2025 — classified as 2 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: 2 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 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 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Application Program Freezes or Fails to Launch1
  • Poor Quality Image1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 3, 2025Poor Quality Image; Poor Quality Image

    IT WAS REPORTED THAT AN IMAGE QUALITY ISSUE OCCURRED ON THE EPIQ CVX ULTRASOUND SYSTEM DURING AN UNSPECIFIED SURGERY AND THE PROCEDURE WAS STOPPED. A PHILIPS SERVICE ENGINEER REPLACED THE ACQUISITION MODULE TO RESOLVE THE CUSTOMER'S IMMEDIATE CONCERNS. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. NO FURTHER 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 21769851 ↗
  • MalfunctionApr 3, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

    IT WAS REPORTED THAT, WHEN CONNECTING THE X8-2T TRANSDUCER OR X5-1 TRANSDUCER, THE EPIQ CVX ULTRASOUND SYSTEM DISPLAYED A MESSAGE REGARDING TRANSDUCER CONNECTION. THE ISSUE OCCURRED DURING AN UNSPECIFIED SURGERY AND THE PROCEDURE WAS STOPPED. A PHILIPS SERVICE ENGINEER REPLACED THE ACQUISITION MODULE TO RESOLVE THE CUSTOMER'S IMMEDIATE CONCERNS. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. NO FURTHER 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 21769847 ↗

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Sources and updates

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