The Recall Desk
ModerateFDA (Devices)·Z-0910-2015·Announced 2015-01-14

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.

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: 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
Hazard
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

Distributed in 6 states:

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