FDA-Device2014-10-15Class II
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Mckesson Information Solutions LLC
Hazard
Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
Sold states
Worldwide distribution: US (nationwide) including states of: AR, CA, FL, DE, GA, HI, IL, IN, KS, LA, MA, MD, MN, MO, MS, MT, NJ, NV, OK, PA, SC, TNTX, , UT, WA; and countries of: Australia, Canada, Israel and the United Kingdom.
Affected count
272 devices
Manufactured in
5995 Winward Plaza, Information Technology Business, Alpharetta, GA, United States
Products
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0042-2015Don't want to check this manually?
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