IBM iConnect Access 8.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842000101017), received between Feb 9, 2022 and Feb 8, 2023 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2023Computer Software Problem; Computer Software Problem

  MERGE HEALTHCARE'S ICONNECT ACCESS APPLICATION PROVIDES INTERNET ACCESS TO MULTI-MODALITY SOFTCOPY MEDICAL IMAGES, REPORTS, AND OTHER PATIENT-RELATED INFORMATION TO CONDUCT DIAGNOSTIC REVIEW, PLANNING AND REPORTING THROUGH THE INTERACTIVE DISPLAY AND MANIPULATION OF MEDICAL DATA. ICONNECT ACCESS PROVIDES HEALTHCARE PROFESSIONAL TOOLS TO AID IN INTERPRETING MEDICAL IMAGES. ON (B)(6) 2023, A MERGE HEALTHCARE EMPLOYEE WAS TESTING MULTIPLE PATIENT ID SEARCHING CAPABILITIES WITH ICONNECT ACCESS (ICA). THE TESTING SCENARIO UTILIZED ONE PATIENT WITH MULTIPLE PIDS TO QUERY RECORDS. DURING THE TESTING, A MULTI-TAB WORKFLOW WAS IDENTIFIED THAT REMOVED FOCUS FROM ONE OF THE PATIENT'S MULTIPLE PIDS. WITH THE FOCUS REMOVED FROM ONE OF THE PIDS, THERE IS A POTENTIAL THAT THE PATIENT'S FILE HISTORY QUERY, AS DISPLAYED ON ONE OF THE TABS WITHIN ICA, MAY BE INCOMPLETE. MERGE HEALTHCARE IS INVESTIGATING THIS INTERNALLY FOUND ISSUE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THERE IS A POTENTIAL, THAT AN INCOMPLETE OR UNNECESSARY TREATMENT PLAN IS IMPLEMENTED BASED ON AN INCOMPLETE DATA SET. THIS IS AN INTERNALLY FOUND ISSUE. THERE HAVE BEEN NO REPORTS OF PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326873 ↗
• MalfunctionFeb 9, 2022Application Program Problem: Parameter Calculation Error; Defective Component; Application Program Problem: Parameter Calculation Error; Defective Component

  THE IBM ICONNECT ACCESS APPLICATION PROVIDES INTERNET ACCESS TO MULTI-MODALITY SOFTCOPY MEDICAL IMAGES, REPORTS, AND OTHER PATIENT-RELATED INFORMATION TO CONDUCT DIAGNOSTIC REVIEW, PLANNING AND REPORTING THROUGH THE INTERACTIVE DISPLAY AND MANIPULATION OF MEDICAL DATA. IBM ICONNECT ACCESS PROVIDES HEALTHCARE PROFESSIONAL TOOLS TO AID IN INTERPRETING MEDICAL IMAGES. ON 1/11/2022, 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 ICONNECT ACCESS 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502374 ↗