FDA-Device2014-10-29Class II
McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Mckesson Information Solutions LLC
Hazard
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
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Australia, Botswana, Canada, Germany, New Zealand, Netherlands, Pakistan, Portugal, South Africa, Turkey and The United Kingdom.
Affected count
625 devices
Manufactured in
5995 Winward Plaza, Information Technology Business, Alpharetta, GA, United States
Products
McKesson Cardiology Hemo. McKesson Cardiology" Hemo is 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-0093-2015Don't want to check this manually?
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