Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0093-2015·Announced 2014-10-29

McKesson Cardiology Hemo Software Recall Due to Insufficient Maintenance Communication

McKesson Information Solutions LLC is recalling 625 McKesson Cardiology Hemo devices because communication regarding required annual maintenance testing was insufficient.

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 describes an administrative failure (insufficient communication) regarding maintenance rather than a direct defect causing injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

McKesson Information Solutions LLC is recalling 625 units of the McKesson Cardiology Hemo device. This software is intended for complete physiological and hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. The affected versions include 11.0HF5, 11.1, 11.1SP5, 11.1SP6, 11.1SP6HF1, 11.1SP6HF3, 12SP1, 12.1, 12.1HF1, 12.1HF2, 12.2, 12.2HF1, 12.2HF2, 12.2HF3, and 12.2HF4.

The recall was initiated because McKesson identified that its communication to customers regarding required maintenance tests was insufficient. The front-end parameter boxes of these devices must undergo annual maintenance testing to establish proper functioning and to identify in a timely manner whether a parameter box is out of calibration. While each unit has an attached sticker, the source text indicates the communication regarding these requirements was inadequate.

The devices were distributed worldwide, including in the United States (nationwide), Australia, Botswana, Canada, Germany, New Zealand, the Netherlands, Pakistan, Portugal, South Africa, Turkey, and the United Kingdom. The source text does not specify specific actions for consumers or healthcare providers beyond the context of the recall.

The recalled product

Product: McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Manufacturer: Mckesson Information Solutions LLC
Category: Medical Device — Monitoring Software
Hazard: mis-labeling
maintenance-failure
Affected units: 625

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 (15)

McKesson Cardiology TM Hemo versions: 11.0HF5
11.1
11.1SP5
11.1SP6
11.1SP6HF1
11.1SP6HF3
12SP1
12.1
12.1HF1
12.1HF2
12.2
12.2HF1
12.2HF2
12.2HF3
12.2HF4.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Mckesson Information Solutions LLC

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Same hazard · mis labeling