FDA-Device2015-01-14Class II
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.
McKesson Israel Ltd.
Hazard
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.
Sold states
Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
Affected count
9
Manufactured in
4 Nehoshet St., or Towers, Bldg. B, Tel Aviv, N/A, Israel
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0910-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief