The Recall Desk
HighFDA (Devices)·Z-1773-2021·Announced 2021-06-09

Change Healthcare Enterprise Viewer software defect affects image display settings

A software defect in Change Healthcare Enterprise Viewer versions 2.0 and 2.1 prevents the display of image presentation styles. The viewer is used nationwide for displaying medical images.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA medical device software defect with no reported illnesses or injuries. It is a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.

Plain-English summary

Change Healthcare Enterprise Viewer is a software application for displaying DICOM and non-DICOM medical images, reports, and multimedia content on standard computer hardware. Software versions 2.0 and 2.1 contain a defect in which image presentation styles that are defined in associated systems are not displayed in the viewer.

The recalled software is distributed nationwide across 33 locations in the following states: Alaska, Arizona, Arkansas, California, Florida, Hawaii, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Mississippi, Nebraska, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington, Wisconsin, and Wyoming.

Affected healthcare facilities should contact Change Healthcare Canada Company, the manufacturer, to obtain a corrected software version.

The recalled product

Product
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 multimedia content.
Manufacturer
CHANGE HEALTHCARE CANADA COMPANY
Category
Medical Device — Medical Imaging Software
Hazard
  • software-defect
  • display-failure
  • diagnostic-accuracy-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software version 2.0 and 2.1.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category