medical Class II Updated 2018-09-12

McKesson Israel Ltd. recalls McKesson Cardiology Hemo, Release SW version 13.0. Used for

Recalled 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.


Hazard / Issue

Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.

Issued by

FDA

Affected States: CA, CO, CT, FL, GA, KS, IN, LA, NJ, NY, OK, OH, SC, TX
Lot/Code Info: software versions: 13.0 HF1, 13.0HF2, 13.0HF3
View official government recall

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