Change Healthcare Cardiology Software Defect May Cause Incorrect Medication Administration
A software defect in Change Healthcare's Cardiology Hemodynamics software may cause clinicians to administer incorrect medications. The defect affects an autosave mechanism and has been distributed nationwide and internationally.
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 a risk-of-harm medical device defect where the potential for serious harm (incorrect medication administration) exists but no illnesses or injuries have been reported. The FDA's Class II classification without reported hospitalizations does not meet the threshold for a Severe rating.
Plain-English summary
Change Healthcare Cardiology Hemodynamics software, version 15.01, is being recalled due to a defect in its autosave mechanism.
The software defect may result in clinicians administering incorrect medications to patients. The defect affects the autosave functionality and could lead to medication errors during clinical use.
The affected software has been distributed nationwide across all US states and internationally to Australia, Israel, Canada, Germany, Ireland, and the United Kingdom. Two units of the software have been identified as part of this recall.
Healthcare providers using this software should contact the manufacturer, A L I Technologies Ltd, for guidance on addressing this defect.
The recalled product
- Product
- Change Healthcare Cardiology Hemodynamics software
- Manufacturer
- A L I Technologies Ltd
- Hazard
- medication-error
- software-defect
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 15.01/UDI:(01)17540262100129
Distribution
Distributed nationwide across the United States.
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