Z-0910-2015 Class II Terminated

Recalled by McKesson Israel Ltd. — Tel Aviv, N/A

Recall Details

Product Type
Devices
Report Date
January 14, 2015
Initiation Date
December 19, 2014
Termination Date
February 25, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9

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.

Distribution Pattern

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

Code Information

MC13.1 and MC13.1.1