CX50 Diagnostic Ultrasound System 989605384711Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00884838025295), received between Mar 2, 2022 and Dec 29, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (2 reports).

2 FDA recall records name this device's 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, 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.

Recalls naming this device

1. 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 ↗

2. 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 problems

Recent adverse event reports

The 11 most recent of 11 reports, 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 ↗
• 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 ↗
• 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 ↗