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
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 ↗
Other System, Imaging, Pulsed Doppler, Ultrasonic devices
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- Transducer S7-3t 989605439232Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls4 reports
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- ACUSON Redwood Diagnostic Ultrasound System 11503314Siemens Medical Solutions USA, Inc. · System, imaging, pulsed doppler, ultrasonic3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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