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McKesson Israel Ltd. recalls McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. Mc
Recalled September 12, 2018 · FDA recall Z-2968-2018 · McKesson Israel
Hazard
Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals. · FDA Class II
Units
31 units
Sold at
US Distribution to states of: CA, CO, CT, FL, GA, KS, IN, LA, NJ, NY, OK, OH, SC, and TX; and internationally to: UK.
Description
Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
Product
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.
Manufacturer(s)
McKesson Israel Ltd.
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →