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
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 ↗
Other System, imaging, pulsed doppler, ultrasonic devices
- Transducer C5-1 989605412042Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic11 recalls0 reports
- Transducer X5-1 989605400802Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic10 recalls0 reports
- EPIQ 7 Diagnostic Ultrasound System 989605386721Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls2 deaths146 reports
- Transducer S7-3t 989605406772Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic5 recalls1 death18 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · System, imaging, pulsed doppler, ultrasonic199 reports
- Transducer S7-3t 989605439232Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls4 reports
- Transducer 3D9-3v 989605395622Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls1 report
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page