Change Healthcare Radiology Software Version 14.2.2 Display Issue
Change Healthcare Radiology Solutions software version 14.2.2 has a display issue where radiology reports may not fully appear when viewing. Healthcare facilities should contact the manufacturer for a fix.
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 an FDA Class II recall involving a software display issue that prevents full visibility of radiology reports. While this represents a risk of diagnostic error if reports cannot be fully reviewed, no hospitalizations, serious injuries, or illnesses have been reported. The score reflects risk-of-harm in a medical context where actual injury has not yet been documented.
Plain-English summary
Change Healthcare Radiology Solutions software version 14.2.2 is subject to this recall due to a software issue that prevents radiology reports from displaying fully when users attempt to view them.
Incomplete display of radiology reports may prevent healthcare professionals from accessing critical diagnostic information. The software is deployed at healthcare facilities in the United States and Canada.
Healthcare facilities currently using Change Healthcare Radiology Solutions software version 14.2.2 (UDI: 01 17540262030068) should contact the manufacturer for a corrected software version and guidance on mitigation steps during the interim period.
The recalled product
- Product
- Change Healthcare Radiology Solutions software version 14.2.2
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Hazard
- incomplete-display
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)
- Version 14.2.2/UDI: (01)17540262030068
Distribution
Distributed nationwide across the United States.
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