McKesson Israel Ltd. recalls McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute…

Recall date

December 19, 2014

Source

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

Recall number

Z-0910-2015

FDA classification

Class II

Brand / firm

McKesson Israel Ltd.

Sold / distributed

Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.

Why it was recalled

An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.

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 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.