Oct

2014

Cl II McKesson Cardiology” Hemo

Company: Mckesson Information Solutions LLC.
Date of Enforcement Report:10/15/2014
Class lI:

PRODUCT

McKesson Cardiology” Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Recall Number Z-0042-2015

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

RECALLING FIRM/MANUFACTURER
Mckesson Information Solutions LLC, Alpharetta, GA on 8/27/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
272 devices

DISTRIBUTION
USA and Internationlaay

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II McKesson Cardiology” Hemo

Amy Sellers

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