Merge PACS 8.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842000100805), received between Aug 6, 2020 and Jul 9, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (2 reports).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K192455); they may or may not involve this specific model.

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. Aug 6, 2020Class IITerminated

   Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

   Z-2944-2020 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 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 6/16/2021, 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. THIS ISSUE HAS BEEN CORRECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144440 ↗
• MalfunctionMay 25, 2021Computer Software Problem; Computer Software Problem

  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 4/27/2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT A DIFFERENT PATIENT'S PRIOR STUDY WAS SHOWING IN THE THUMBNAIL VIEW FOR A CURRENT STUDY OPEN IN THE PRIMARY VIEWER. MERGE HEALTHCARE SUPPORT WORKED WITH THE CUSTOMER TO REPRODU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881109 ↗
• MalfunctionAug 6, 2020Computer Software Problem; Application Program Problem: Parameter Calculation Error; Computer Software Problem; 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.). ON (B)(6) 2020, MERGE HEALTHCARE RECEIVED A REPORT FROM A CUSTOMER THAT HOUNSFIELD UNIT VALUES REPORTED IN THE 3D VIEW WERE INCONSISTENT WITH THE HOUNSFIELD UNIT VALUES REPORTED IN THE 2D VIEW OF MERGE PACS. UPON INVESTIGATION, IT WAS DISCOVERED THAT PIXEL VALUE MEASUREMENTS (INCLUDING HOUNSFIELD UNIT MEASUREMENTS AND SUV MEASUREMENTS) FROM THE PROBE, ROI, AND REGION ANALYSIS AREA TOOLS ARE INCORRECT ON MULTI-PLANAR REFORMATS (MPRS)

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10375493 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192455. One submission often covers many models, so check the product and lot details in each record.

• Z-3004-2026 · Jul 22, 2026 · Open, Classified
  Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
• Z-2875-2026 · Jun 30, 2026 · Open, Classified
  Merge OrthoPACS, medical imaging diagnostic workstation
• Z-2874-2026 · Jun 30, 2026 · Open, Classified
  Merge PACS, medical imaging diagnostic workstation