Merge PACS 6.6.3.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842000100508), received between May 14, 2020 and May 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

13 other recalls cover devices cleared under the same FDA submission (K082144); 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.

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.

• MalfunctionMay 14, 2020Computer 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 STAND ALONE OR TO INTEGRATE WITH VENDOR-NEUTRAL IMAGING ARCHIVES (VNAS) SUCH AS I CONNECT 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, THE CUSTOMER REPORTED THAT A STUDY CAME IN AND THE CT TECH MANUALLY CHANGED FROM UNVERIFIED TO UNREAD AND SET THE CUSTOM STATUS TO ER. IT UPDATED EVERYTHING AS EXPECTED AND SHOWED ON THE RADIOLOGST'S ER WORKLIST. A LITTLE LATER, THE CT TECH SENT IN SCANNED PAPERWORK, WHICH REVERTED THE STATUS BACK TO UNVERIFIED, THEREBY, REMOVING THE STUDY FROM THE RADIOLOGIST'S ER WORKLIST (WHICH IS EXPECTED BEHAVIOR). HOWEVER, THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10057595 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082144. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2017 · May 24, 2017 · Terminated
  Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
• Z-2591-2017 · May 8, 2017 · Terminated
  Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital
• Z-2590-2017 · May 8, 2017 · Terminated
  Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
• Z-1431-2017 · Apr 4, 2016 · Terminated
  Merge PACS software. The firm name on the label is Merge Healthcare.
• Z-1176-2017 · Apr 4, 2016 · Terminated
  Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
• Z-0599-2017 · Mar 28, 2016 · Terminated
  Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies prod
• Z-0726-2017 · Mar 28, 2016 · Terminated
  Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital
• Z-2363-2016 · Feb 5, 2016 · Terminated
  Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy fr
• Z-2301-2016 · Jan 30, 2016 · Terminated
  Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a
• Z-2379-2016 · Jan 30, 2016 · Terminated
  Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
• Z-2303-2016 · Jan 30, 2016 · Terminated
  Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dime
• Z-2531-2016 · Jan 30, 2016 · Terminated
  iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TC
• Z-2532-2016 · Jan 30, 2016 · Terminated
  iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TC