FDA-Device2018-09-12Class II
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting v
McKesson Israel Ltd.
Hazard
Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
Sold states
US Distribution to states of: CA, CO, CT, FL, GA, KS, IN, LA, NJ, NY, OK, OH, SC, and TX; and internationally to: UK.
Affected count
31 units
Manufactured in
Or Towers Bldg. B, 4, Nehoshet St., Tel Aviv, N/A, Israel
Products
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2968-2018Don't want to check this manually?
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