Merge PACS 8.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842000100737), received between Jun 14, 2021 and Jun 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (1 report).

1 FDA recall record name this device's identifier.

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 16, 2026.

Recalls naming this device

1. Jul 11, 2019Terminated

   Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

   Z-2062-2019 · Root cause: Software Design Change · 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.

• MalfunctionJun 14, 2021Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  MERGE PACS IS A STANDARDS-BASED MEDICAL IMAGING DIAGNOSTIC WORKSTATION THAT SERVES AS AN ADJUNCT TO ASSIST THE CLINICIAN TO VIEW, READ, AND REPORT THEIR FINDINGS. MERGE PACS PROCESSES AND DISPLAYS MEDICAL IMAGES FROM DICOM-COMPLIANT MODALITIES. THE DEVICE IS DESIGNED TO ENABLE EFFICIENT WORKFLOWS BY MAINTAINING CLINICIANS' WORKLISTS AND RETRIEVING AND MANAGING STUDIES FOR READING, REPORTING, COMMUNICATION, AND STORAGE. MERGE PACS SOFTWARE RUNS ON OFF-THE-SHELF COMPUTER HARDWARE AND CAN BE CONFIGURED TO OPERATE STANDALONE OR TO INTEGRATE WITH VENDOR-NEUTRAL IMAGING ARCHIVES (VNAS) SUCH AS ICONNECT ENTERPRISE ARCHIVE (ICEA) FOR IMAGE STORAGE, AND WITH RADIOLOGICAL AND HOSPITAL INFORMATION SYSTEMS (RIS AND HIS) AND MEDICAL RECORD SYSTEMS (EMR, EHR, ETC.). MERGE PACS CAN BE ACCESSED FROM WITHIN THE HOSPITAL OR ENTERPRISE, OR FROM REMOTE LOCATIONS VIA WEB-BASED ACCESS. IMAGES VIEWED ON MOBILE DEVICES MUST NOT BE USED FOR DIAGNOSTIC REVIEW. ON (B)(6) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REPORT THAT THERE WERE DISCREPANT ROI (REGION OF INTEREST) VALUES BETWEEN 2D AND MPR IMAGES. MERGE HEALTHCARE SUPPORT WORKED WITH THE CUSTOMER TO REPRODUCE THE ISSUE. THE ISSUE IS CONFINED TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996143 ↗