Change Healthcare Cardiology Hemo Software Unexpected Shutdown Risk
Change Healthcare is recalling Cardiology Hemo Software (version 14.3.2 and 15.0.1) because a software update may cause the system to unexpectedly shut down. The recall affects 29 systems distributed across multiple US states and international locations.
What this means for you
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: This is an FDA Class II medical device recall. No illnesses or injuries have been reported in the source text, and the hazard is a software function issue rather than a direct patient safety threat. The classification by the regulating agency supports a Moderate severity rating.
Plain-English summary
Change Healthcare Canada Company is recalling its Cardiology Hemo Software versions 14.3.2 and 15.0.1 due to complaints that a software update may cause the software to unexpectedly shut down.
The recalled software affects 29 systems that have been distributed nationwide in the United States (including Alabama, Arkansas, California, Florida, Kentucky, Missouri, Mississippi, Nebraska, New Hampshire, New Jersey, Pennsylvania, Tennessee, Texas, and Washington) as well as in Australia, Canada, Germany, Great Britain, Ireland, Israel, and New Zealand.
Healthcare facilities and clinicians currently using this software should contact Change Healthcare Canada Company for guidance regarding the software update and appropriate mitigation steps.
The recalled product
- Product
- Change Healthcare Cardiology Hemo Software
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Hazard
- software-malfunction
- system-shutdown
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 14.3.2/UDI: (01)17540262100051/ 15.0.1/UDI: (01)17540262100105
Distribution
Distributed nationwide across the United States.
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