Change Healthcare Enterprise Viewer 2.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 17540262010039), received between Mar 15, 2021 and Apr 19, 2021 — classified as 2 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K181185); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2021Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  THE CUSTOMER REPORTED THAT WHEN VIEWING STUDIES IN CHEV, THEY DID NOT RETAIN THE PRESENTATION STATE FROM THE SAME STUDY IN PACS. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11689299 ↗
• MalfunctionMar 15, 2021Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  A NEUROSURGEON INITIALLY MISINTERPRETED ANCHOR IMAGES DISPLAYED IN THE VIEWPORT OF THE CHANGE HEALTHCARE ENTERPRISE VIEWER (CHEV) AS A PRIOR STUDY. IT WAS REPORTED THIS CAUSED THE NEUROSURGEON TO ALMOST USE THE WRONG IMAGE FOR SURGERY. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488096 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181185. One submission often covers many models, so check the product and lot details in each record.

• Z-1773-2021 · Apr 19, 2021 · Open, Classified
  Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and m
• Z-1508-2021 · Mar 17, 2021 · Open, Classified
  Change Healthcare Enterprise Viewer