Change Healthcare Cardiology Hemodynamics Software May Unexpectedly Shutdown
Change Healthcare Cardiology Hemodynamics Software version 15.0.1 is being recalled due to complaints that a software update may cause the application to unexpectedly shutdown. The affected software was distributed to 4 systems worldwide.
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 affecting critical patient monitoring software. No illnesses or injuries have been reported. The hazard—unexpected software shutdown—is based on customer complaints but lacks documentation of actual patient harm. The potential for a cardiac hemodynamics system to unexpectedly shutdown poses an implicit risk to patient safety, but the absence of injury reports and the theoretical nature of the reported hazard warrant a High severity classification.
Plain-English summary
Change Healthcare Cardiology Hemodynamics Software version 15.0.1 is the subject of an FDA Class II recall due to complaints that a software update may cause the application to unexpectedly shutdown.
This cardiology hemodynamics software could experience unexpected shutdown, which could disrupt its intended cardiac monitoring and analysis functions. Four systems with this software have been distributed worldwide, including across the United States in the states of Alabama, Arkansas, California, Florida, Kentucky, Missouri, Mississippi, Nebraska, New Hampshire, New Jersey, Pennsylvania, Tennessee, Texas, and Washington.
International distribution occurred in Australia, Canada, Germany, Great Britain, Ireland, Israel, and New Zealand. The affected software is version 15.0.1, identified by UDI (01)17540262100129.
The recalled product
- Product
- Change Healthcare Cardiology Hemodynamics Software
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Hazard
- unexpected-shutdown
- software-failure
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: 15.0.1/UDI: (01)17540262100129
Distribution
Distributed nationwide across the United States.
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