Merge Cardio 12.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842000100065), received between Oct 28, 2023 and Oct 28, 2023 — classified as 1 malfunction.

1 FDA recall record name this device's identifier, 1 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. Feb 19, 2025Class IIOpen, Classified

   When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

   Z-1402-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2023No Apparent Adverse Event; No Apparent Adverse Event

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION FROM MERGE HEALTHCARE AND OTHER VENDORS SYSTEMS INCLUDING IMAGES, HEMODYNAMIC STUDIES AND REPORTS, MEASUREMENTS (VIA IMPORT FROM DICOM STRUCTURED REPORTING, TEXT FILES OR OPTICAL CHARACTER RECOGNITION OF MEASUREMENTS CAPTURED ON IMAGES) AND CARDIOLOGY SIGNAL (WAVEFORM) DATA. MERGE CARDIO IS INTENDED TO ALLOW USERS TO REVIEW DIAGNOSTIC AND NON-DIAGNOSTIC QUALITY IMAGES, ANNOTATE STUDIES, PERFORM DIGITAL SUBTRACTION ON IMAGES, TO PERFORM QUANTITATIVE MEASUREMENTS ON IMAGES (INCLUDING BUT NOT LIMITED TO QUANTITATIVE CORONARY ANALYSIS, LEFT VENTRICULAR ANALYSIS, TIME, AREA, LENGTH, VELOCITY, ANGLE, VOLUME, AND VELOCITY-TIME INTEGRALS), TO GENERATE PHYSICIAN GENERATED CLINICAL REPORTS (VIA STRUCTURE REPORTING AND TEMPLATE BASED TOOLS), AND TO STORE THIS INFORMATION IN A DATABASE. ON 10/20/2023, MERGE HEALTHCARE WAS NOTIFIED VIA EMAIL THAT A MEDICAL DEVICE REPORT (B)(4) CONCERNING OUR PRODUCT WAS SUBMITTED TO THE FDA VIA THE MEDWATCH PROGRAM. MERGE HEALTHCARE HAS BEEN IN CONTACT WITH THE CUSTOMER. A SERVICE CASE, (B)(4), WAS OPENED ON (B)(6) 2023. THE CUSTOMER ALLEGED THAT EX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026719 ↗