Clarius Ultrasound Scanner Clarius Scanner C3 HD3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07540205001189), received between Oct 17, 2024 and Nov 25, 2024 — 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionNov 25, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  A SCANNER MALFUNCTION DUE TO A CORRUPTED SD CARD DELAYED DIAGNOSTIC IMAGING FOR A PATIENT WITH LOW OXYGEN LEVELS AND ELEVATED WHITE CELL COUNT. LUNG AUSCULTATION SUGGESTED PNEUMONIA, WHILE A CHEST X-RAY RAISED CONCERNS ABOUT PULMONARY CONGESTION. THE PATIENT'S CONDITION WORSENED, REQUIRING INCREASED OXYGEN SUPPORT AND EVENTUAL TRANSFER TO A LARGER FACILITY. LIMITED DIAGNOSTICS PREVENTED TIMELY INTERVENTION WITH DIURETICS, BUT THE DELAY DID NOT RESULT IN DEATH OR SEVERE HEALTH DETERIORATION. THE MALFUNCTION WAS RESOLVED WITH CUSTOMER SUPPORT ASSISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774543 ↗
• MalfunctionOct 17, 2024Misconnection; Misconnection

  DURING A DIAGNOSTIC EVALUATION IN AN EMERGENCY ROOM IN CANADA, A PHYSICIAN ENCOUNTERED A CONNECTIVITY ISSUE WITH CLARIUS ULTRASOUND SCANNER C3 HD3 WHILE ATTEMPTING TO ASSESS A PATIENT PRESENTING WITH ABDOMINAL PAIN AND SUSPECTED FLUID ACCUMULATION. THE MALFUNCTION DID NOT RESULT IN DEATH, SERIOUS INJURY, OR ANY SIGNIFICANT ADVERSE DEVICE-RELATED OUTCOMES. HOWEVER, THE MALFUNCTION CAUSED A DELAY IN DIAGNOSTIC THAT COULD HAVE EXACERBATE THE PATIENT'S CONDITION AND LEAD TO A DEATH, SERIOUS INJURY OR SIGNIFICANT DEVICE EXPERIENCE IF IT WERE TO REOCCUR IN AN EMERGENCY ENVIRONMENT. THE EVENT WAS REPORTED TO CLARIUS ON SEPTEMBER 11TH, 2024 AND THE CLARIUS SCANNER C3 HD3 HAS BEEN CLEARED BY THE FDA UNDER 510(K) #K213436. THE MALFUNCTION IDENTIFIED UNDER THIS REPORT OCCURRED DUE TO A CONNECTION ISSUE BETWEEN CLARIUS APP AND CLARIUS SCANNER BECAUSE OF A CLARIUS APP PILOT UPDATE ( CLARIUS APP 11.3.1 TO CLARIUS APP 11.3.2). THE ISSUE WAS SUCCESSFULLY RESOLVED BY UNINSTALLING AND THEN REINSTALLING THE APPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471171 ↗