McKesson Cardiology ECG Management It is a software application designed to import, display, s...
FDA Recall #Z-0910-2015 — Class II — December 19, 2014
Product Description
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.
Reason for Recall
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.
Recalling Firm
McKesson Israel Ltd. — Tel Aviv, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9
Distribution
Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
Code Information
MC13.1 and MC13.1.1
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated