Change Healthcare Radiology Software Recall for Potential Missing Images
Change Healthcare is recalling Radiology Solutions 14.0 software due to a defect that may cause images to be missing from studies.
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: The recall involves a risk-of-harm product (medical software) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Change Healthcare Canada Company is recalling 5 units of Change Healthcare Radiology Solutions 14.0 software. The recall was initiated due to a software defect that may potentially result in one or more images missing in a study.
The affected software was distributed domestically to Vermont, Mississippi, West Virginia, and Nebraska. The specific model number is 14.0, and the UDI is (01)17540262030020(10)140000.
Consumers and healthcare providers should contact Change Healthcare Canada Company for instructions on how to resolve the software defect.
The recalled product
- Product
- Change Healthcare Radiology Solutions 14.0
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Category
- Medical Device — Software
- Affected units
- 5
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)
- All Model number 14.0 UDI (01)17540262030020(10)140000
Distribution
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