Radiology software may fail to update patient records in external systems
Change Healthcare Radiology Solutions versions 14.0, 14.1, and 14.2 may fail to update records in external applications. Healthcare facilities using this software are affected across six countries.
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 medical device recall for a software defect that may prevent proper data synchronization in a healthcare system. While no illnesses or injuries have been reported, the failure of a radiology information system to update external records constitutes a risk-of-harm product, as incomplete patient information could lead to clinical errors or delayed diagnosis.
Plain-English summary
Change Healthcare Radiology Solutions, versions 14.0, 14.1, and 14.2, is a medical image and information management system used by healthcare organizations. The FDA has issued a Class II recall due to a software issue in these versions.
The software may fail to update records in external applications. This means that changes made in the radiology system may not be transmitted to other systems that depend on that information, potentially resulting in incomplete or out-of-date patient information being available to clinicians in connected systems.
Approximately 282 units of this software are distributed across healthcare facilities in the United States, Canada, Ireland, Saudi Arabia, France, and the United Kingdom.
Healthcare facilities using affected versions should contact Change Healthcare for software updates. Facilities should verify that critical patient information is being properly synchronized across all connected systems.
The recalled product
- Product
- Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Hazard
- failed-record-update
- incomplete-medical-records
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)
- UDI/DI 17540262030020
Distribution
Distribution scope not specified by the agency.
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