Merge PACS 8.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842000100935), received between Feb 9, 2022 and Feb 9, 2022 — classified as 1 malfunction.

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

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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 9, 2022Application Program Problem: Parameter Calculation Error; Defective Component; Application Program Problem: Parameter Calculation Error; Defective Component

  MERGE PACS IS A MEDICAL IMAGE AND INFORMATION MANAGEMENT SYSTEM THAT IS USED FOR VIEWING, SELECTION, PROCESSING, PRINTING, TELECOMMUNICATIONS, AND MEDIA INTERCHANGE OF MEDICAL IMAGES FROM A VARIETY OF DIAGNOSTIC IMAGING SYSTEMS. ON (B)(6) 2022, MERGE HEALTHCARE RECEIVED AN EMAIL NOTIFICATION FROM AN APPROVED SUPPLIER, (B)(4). (B)(4) PROVIDES A 3D MEDICAL IMAGING SOFTWARE TOOLKIT THAT IS USED WITH MERGE PACS TO RENDER DICOM COMPLIANT 3D IMAGES FOR VIEWING. THE EMAIL PROVIDED INFORMATION REGARDING A REQUIREMENT THAT WAS NOT FULLY IMPLEMENTED WITHIN (B)(4) 3D MEDICAL IMAGING TOOLKIT. THE REQUIREMENT IS THAT: X AND Y PIXEL SPACING MUST BE EQUAL FOR DATA LOADED INTO 3D IMAGE RENDERING ENGINES. PER (B)(4), "ALTHOUGH CROSS SECTIONAL 3D IMAGING DATA ALMOST ALWAYS HAS EQUAL X & Y SPACING AS ADDITIONAL ASSURANCE, AND TO PROTECT FROM THE RARE EVENTS THEY ARE NOT EQUAL, OUR NEXT RELEASE OF THE SDK WILL NOW NOT ALLOW THIS DATA TO LOAD INTO 3D RENDER ENGINES (2D RENDER ENGINES WILL CONTINUE TO SUPPORT IT)." MERGE HEALTHCARE HAS RECEIVED NO COMPLAINTS FROM CUSTOMERS OR USERS OF MERGE PACS REGARDING THE RENDERING OF NON-SQUARE X,Y PIXEL 3D IMAGES. MERGE HEALTHCARE, IN CONVERSATIONS WITH (B)(6) MED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502451 ↗