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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 33
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
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