Company:McKesson Israel Ltd..
Date of Enforcement Report 1/8/2015
Class lI:
PRODUCT
McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
Recall Number Z-0910-2015
REASON
Software error discovered in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.
RECALLING FIRM/MANUFACTURER
McKesson Israel Ltd., Tel Aviv, Israel, on 12/19/2014. Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9
DISTRIBUTION
USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
___________________________________
