CX50 Diagnostic Ultrasound SystemRecalls & reported problems across all models
Philips Ultrasound LLC · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one CX50 Diagnostic Ultrasound System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of CX50 Diagnostic Ultrasound System by Philips Ultrasound LLC in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between Feb 1, 2021 and Dec 29, 2025 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (3 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
CX50 Diagnostic Ultrasound System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 3, 2025Class IIIOpen, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-2394-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 3, 2025Class IIIOpen, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-2389-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported CX50 Diagnostic Ultrasound System problems
Device problems
- Application Program Freezes or Fails to Launch3
- Failure to Power Up2
- No Device Output2
- Application Program Problem1
- Device Tipped Over1
- Electrical /Electronic Property Problem1
- Insufficient Device Problem Information1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information1
- No Consequences Or Impact To Patient1
CX50 Diagnostic Ultrasound System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CX50 Diagnostic Ultrasound System 989605384711System, imaging, pulsed echo, ultrasonic2 recalls11 reports
- CX50 DIAGNOSTIC ULTRASOUND SYSTEM 795087System, imaging, pulsed doppler, ultrasonic4 reports
Recent CX50 Diagnostic Ultrasound System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
AN NMPA REPORT (B)(4) WAS RECEIVED THAT REPORTED THE CX50 ULTRASOUND SYSTEM COULD NOT BE TURNED ON WHEN NEEDED FOR A PORTABLE BEDSIDE EXAM FOR A CRITICALLY ILL PATIENT. ANOTHER SYSTEM WAS USED FOR THE UNSPECIFIED EXAMINATION. THERE WAS NO PATIENT OR USER HARM. 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 23907052 ↗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 ↗MalfunctionFeb 5, 2025No Device Output; No Device Output
IT WAS REPORTED A FEMALE PATIENT'S PREGNANCY STATUS REQUIRED BEDSIDE ULTRASOUND ASSISTANCE DUE TO INTRAUTERINE STILLBIRTH; THE PATIENT WAS UNDERGOING AN EVACUATION CURETTAGE SURGERY. AFTER THE CX50 ULTRASOUND WAS MOVED TO THE OPERATING ROOM AND TURNED ON, AN ERROR OCCURRED, RESULTING IN THE INABILITY TO TURN ON THE DEVICE. A REPLACEMENT ULTRASOUND WAS IMMEDIATELY USED TO COMPLETE THE PROCEDURE. THERE WAS NO ALLEGATION OF ANY PATIENT IMPACT, AND NO OTHER MEDICAL INTERVENTION WAS REPORTED. 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 21312760 ↗MalfunctionNov 12, 2024No Device Output; No Device Output
IT WAS REPORTED DURING A SURGICAL PROCEDURE A PORTION OF THE CX50 ULTRASOUND SYSTEM IMAGING SCREEN DARKENED AND THE IMAGING FIELD WENT BLANK. THE ULTRASOUND SYSTEM WAS USED FOR GUIDANCE DURING AN INDUCED ABORTION. THERE WAS NO ALLEGATION OF ANY PATIENT IMPACT AND NO OTHER MEDICAL INTERVENTION WAS REPORTED. 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 20668384 ↗MalfunctionNov 8, 2024Application Program Problem; Application Program Problem
IT WAS REPORTED THAT THE CX50 ULTRASOUND SYSTEM COULD NOT BE TURNED ON OR USED DURING ULTRASOUND DIAGNOSIS FOR BEDSIDE EMERGENCY TREATMENT. THE SYSTEM WAS REPLACED TO CONTINUE THE ULTRASOUND DIAGNOSIS. ADDITIONAL INFORMATION REGARDING THE PROCEDURE AT THE TIME OF THE EVENT WAS REQUESTED BUT FURTHER INFORMATION COULD NOT BE OBTAINED. THERE WAS NO REPORTED PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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 20642573 ↗MalfunctionSep 4, 2024Failure to Power Up; Failure to Power Up
AN NMPA REPORT 1264118062024001053 WAS RECEIVED AND REPORTED A CX50 ULTRASOUND SYSTEM WAS UNAVAILABLE DURING AN UNSPECIFIED EMERGENCY EXAMINATION. A BACKUP ULTRASOUND SYSTEM WAS USED FOR THE EXAMINATION. THERE WAS NO REPORTED PATIENT OR USER HARM AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION REGARDING THE NATURE OF THE EXAMINATION AND REPORTED FAILURE COULD NOT BE OBTAINED FROM THE CUSTOMER. THE POWER BOARD WAS REPLACED BY A THIRD PARTY TO RESOLVE THE ISSUE. THE SYSTEM HAS BEEN RETURNED TO SERVICE WITH NO ADDITIONAL ISSUES REPORTED. IF FURTHER INFORMATION BECOMES AVAILABLE OR UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20137181 ↗MalfunctionJun 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
AN NMPA REPORT 1233502042024000124 WAS RECEIVED AND REPORTED A CX50 ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. THE CX50 ULTRASOUND SYSTEM WAS FOUND TO BE UNUSABLE FOR AN UNSPECIFIED REASON WHEN ATTEMPTED TO BE USED FOR A BEDSIDE EXAMINATION AND ULTRASOUND GUIDED INTERNAL JUGULAR VEIN CATHETERIZATION. THE EXAM WAS PERFORMED ON A PATIENT WITH UNSTABLE CIRCULATION AND CONCOMITANT SEPTIC SHOCK. A BACKUP ULTRASOUND SYSTEM WAS USED FOR THE EXAMINATION. THERE WAS NO REPORTED PATIENT OR USER HARM AS A RESULT OF THIS ISSUE. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19548278 ↗MalfunctionMay 9, 2024Poor Quality Image; Poor Quality Image
A MISDIAGNOSIS WAS REPORTED WHEN USING THE CX50 ULTRASOUND SYSTEM AND AN X8-2T TRANSDUCER. THE SYSTEM WAS DISPLAYING HAZY IMAGES WHILE IN USE IN THE CARDIOVASCULAR WARD. THE EXAMINATION WAS COMPLETED, HOWEVER THERE WAS AN UNSPECIFIED MISDIAGNOSIS OR MISTREATMENT OF A PATIENT. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION IS NOT KNOWN CURRENTLY. THE SERVICE ENGINEER CONFIRMED THE ISSUE AND REPLACED THE X8-2T TRANSDUCER. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19277198 ↗MalfunctionApr 2, 2024Unintended Electrical Shock; Unintended Electrical Shock
A USER FACILITY REPORT BFARM 08301/24 WAS RECEIVED THAT REPORTED A SERIOUS INJURY ON 14MAR2024 IN WHICH A DOCTOR'S ASSISTANT PICKED UP THE CX50 ULTRASOUND SYSTEM FOR A PATIENT EXAM AND TOUCHED THE UNINSULATED SECTION OF THE POWER CORD. THE USER RECEIVED AN ELECTRICAL SHOCK TO THE RIGHT HAND. IT WAS UNSPECIFIED IF MEDICAL INTERVENTION WAS REQUIRED AND THE EXTENT OF THE PHYSICAL INJURY FROM THE SHOCK IS CURRENTLY UNKNOWN. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19023182 ↗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 ↗MalfunctionNov 18, 2022Device Tipped Over; Device Tipped Over
A CUSTOMER REPORTED THEIR CX50 ULTRASOUND SYSTEM TIPPED OVER AFTER ENCOUNTERING AN OBSTACLE DURING TRANSPORT WITHIN THE USER FACILITY. THERE WAS NO ALLEGATION OF PATIENT OR USER INJURY AS A RESULT OF THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15826651 ↗MalfunctionOct 12, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
THE CUSTOMER REPORTED THEIR CX50 ULTRASOUND SYSTEM DISPLAYED AN ERROR WHILE TAKING MEASUREMENTS DURING A VALVE REPLACEMENT PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER ULTRASOUND SYSTEM. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE FIELD SERVICE ENGINEER RELOADED THE SOFTWARE TO RESOLVE THE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15587172 ↗MalfunctionMar 2, 2022Unexpected Shutdown; Unexpected Shutdown
A CUSTOMER REPORTED THEIR CX50 ULTRASOUND SYSTEM DISPLAYED A BLANK SCREEN AND SHUT DOWN DURING USE WITH A PATIENT IN AN UNSTABLE CONDITION. THE TYPE OF PROCEDURE BEING PERFORMED IS UNKNOWN AT THIS TIME. A PHILIPS SERVICE ENGINEER REPLACED THE HARD DRIVE AND EBOX TO REPAIR THE SYSTEM. THERE WAS NO ALLEGATION OF ALTERED PATIENT OUTCOME AS A RESULT OF THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13656637 ↗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 Philips Ultrasound LLC products
- Transducer C5-13 models · 0 reports · 12 recalls
- EPIQ Diagnostic Ultrasound System9 models · 281 reports · 5 recalls
- Transducer X5-13 models · 0 reports · 10 recalls
- EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM5 models · 330 reports · 3 recalls
- Transducer C10-3v2 models · 0 reports · 7 recalls
- Transducer X7-2t4 models · 26 reports · 6 recalls
- Transducer C5-210 models · 0 reports · 6 recalls
- Transducer S5-12 models · 0 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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