McKesson Israel Ltd. recalls McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKess…

Recall date

March 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2968-2018

FDA classification

Class II

Brand / firm

McKesson Israel Ltd.

Sold / distributed

US Distribution to states of: CA, CO, CT, FL, GA, KS, IN, LA, NJ, NY, OK, OH, SC, and TX; and internationally to: UK.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.