McKesson Cardiology ECG Management Software Recalled for Incorrect Time Stamps
McKesson Israel Ltd. is recalling McKesson Cardiology ECG Management software versions 13.1 and 13.1.1 because a software error causes incorrect ECG procedure time stamps.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a software error affecting data accuracy (time stamps) rather than a direct physical safety risk, fitting the criteria for a moderate severity recall involving low-risk issues or voluntary precautionary measures.
Plain-English summary
McKesson Israel Ltd. is recalling McKesson Cardiology ECG Management software, versions 13.1 and 13.1.1. The software is designed to import, display, store, analyze, distribute, and manage information related to ECG procedures for adult and pediatric patients from external ECG devices.
The recall is due to a software error that results in incorrect time stamps for ECG procedures. This issue affects 9 units of the software. The affected products were distributed worldwide, including in the United States (Massachusetts, Mississippi, New Hampshire, North Carolina, Texas, and Washington) and internationally to the United Kingdom.
No specific instructions for consumers are provided in the source text. Healthcare facilities using this software should verify their software version and contact the manufacturer for further guidance.
The recalled product
- Product
- McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
- Manufacturer
- McKesson Israel Ltd.
- Category
- Medical Device — Software
- Affected units
- 9
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)
- MC13.1 and MC13.1.1
Distribution
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