Reported Oct 29, 2014 · Terminated

McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring,…

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. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Lot codes and dates
  • 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
Amount recalled
625 devices

Where it was sold

  • Nationwide

Why it was recalled

McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker i

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 Oct 26, 2017 · Data as of Sep 19, 6:12 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.