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

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