Recall – Cardiology Hemo

Company: McKesson Israel Ltd..
Date of Enforcement Report 9/12/2018
Class II:

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

Recall Number: Z-2968-2018

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

RECALLING FIRM/MANUFACTURER
McKesson Israel Ltd., Tel Aviv, Israel on 3/12/2018 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
31

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

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Public Course – Jan 9-11, 2023 – Risk Management (in-person)

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Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.