Merge PACS 9.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842000101154), received between Mar 22, 2025 and Mar 22, 2025 — classified as 1 injury.

2 FDA recall records name this device's identifier, 2 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 16, 2026.

Recalls naming this device

1. Jun 30, 2026Open, Classified

   Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.

   Z-2874-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

2. Jun 30, 2026Open, Classified

   Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.

   Z-2875-2026 · 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.

• InjuryMar 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MERGE HEALTHCARE IS SUBMITTING THIS REPORT TO US FDA DUE TO AN ISSUE WITH A THIRD-PARTY APPLICATION USED FOR REPORTING AND DICTATION THAT LED TO A POTENTIAL PATIENT SAFETY RISK. THE THIRD-PARTY APPLICATION INTEROPERATES WITH THE COMPANY'S MERGE PACS AND MERGE WORKFLOW ORCHESTRATOR PRODUCTS. NEITHER THE THIRD-PARTY APPLICATION NOR MERGE WORKFLOW ORCHESTRATOR ARE REGULATED AS MEDICAL DEVICES. A CUSTOMER CONTACTED MERGE HEALTHCARE TECHNICAL SUPPORT ON (B)(6)2025 TO REPORT THAT A PATIENT'S IMAGING STUDY HAD BEEN READ INCORRECTLY BY A RADIOLOGIST. THE CUSTOMER ALLEGED THAT MERGE PACS AND THE DICTATION SYSTEM DISPLAYED IMAGES FOR THE INCORRECT PATIENT. AS A RESULT, A PATIENT WAS SENT OFFSITE FOR FURTHER TREATMENT. NO PATIENT HARM OCCURRED, AS HOSPITAL STAFF IDENTIFIED THAT THE CLINICAL HISTORY IN THE REPORT DID NOT MATCH THE ORDER REQUISITION FOR THE PATIENT. MERGE HEALTHCARE INITIATED AN INVESTIGATION WITH THE THIRD-PARTY VENDOR FOR THE DICTATION SYSTEM. BASED ON AN ANALYSIS OF THE SYSTEM LOG FILES, IT WAS DETERMINED THAT THE USER HAD OPENED TWO PATIENT EXAMS IN QUICK SUCCESSION. THE RESULTS OF THE INVESTIGATION CONCLUDED THAT THE CORRECT IMAGES FOR THE PATIENT WERE DISPLAYED BY MERGE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21671425 ↗