McKesson Cardiology Hemo Software Autosave Defect May Cause Medication Errors
A software defect in McKesson Cardiology Hemo's autosave mechanism may cause clinicians to administer incorrect medications. The FDA has issued a Class II recall.
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: FDA Class II recall with no reported illnesses or injuries. The defect creates a risk of harm through potential medication errors, which aligns with the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
McKesson Cardiology Hemo software is being recalled due to a defect in its autosave mechanism. Affected versions include 13.1.2, 13.2.1, and version 14.
The autosave defect may result in clinicians administering incorrect medications. This poses a risk to patient safety in cardiology operations.
The software has been distributed nationwide across the United States and internationally, including in Australia, Israel, Canada, Germany, Ireland, and the United Kingdom.
The FDA has classified this as a Class II recall. Healthcare providers using this software should contact the manufacturer, A L I Technologies Ltd, for guidance on remediation.
The recalled product
- Product
- McKesson Cardiology Hemo 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 (3)
- Software versions: 13.1.2/No UDI
- 13.2.1/UDI:(01)80010939050010
- 14/(01)80010939050027
Distribution
Distributed nationwide across the United States.
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