Change Healthcare Enterprise Viewer Software Recall for Display Defect
Change Healthcare is recalling Enterprise Viewer software versions 2.0 and 2.1 due to a defect that may prevent anchor studies from displaying.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a software defect that may cause a display failure without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures where harm is not explicitly reported.
Plain-English summary
Change Healthcare Canada Company is recalling 28 units of Change Healthcare Enterprise Viewer software, specifically versions 2.0 and 2.1. The recall is due to an identified intermittent software defect that may result in an anchor study failing to display.
The affected software was distributed domestically in the following states: Indiana, Kentucky, California, New York, Washington, Illinois, Iowa, Florida, Texas, Michigan, Hawaii, Alaska, Wisconsin, Wyoming, Nebraska, Arizona, Ohio, and Pennsylvania.
Consumers and healthcare providers should contact Change Healthcare for further instructions regarding the software defect and potential remediation.
The recalled product
- Product
- Change Healthcare Enterprise Viewer
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Category
- Medical Device — Software
- Affected units
- 28
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)
- Change Healthcare Enterprise Viewer 2.0 and 2.1
Distribution
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