Reported Oct 15, 2014 · Terminated

McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition,…

Mckesson Information Solutions LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mckesson Information Solutions LLC · 5995 Winward Plaza · Alpharetta, GA · 30005

Is this the product you have?

  • McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Lot codes and dates
  • McKesson CardiologyTM Hemo versions
    • 13.0
    • 13.0HF1
    • 13.0HF2
    • 13.0HF3
    • 13.1
Amount recalled
272 devices

Where it was sold

Why it was recalled

Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 18, 2016 · Data as of Sep 19, 6:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.