Reported Jan 14, 2015 · Terminated

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

McKesson Israel Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: McKesson Israel Ltd. · 4 Nehoshet St., or Towers · Tel Aviv, N/A · N/A

Is this the product you have?

  • 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.
Lot codes and dates
  • MC13.1 and MC13.1.1
Amount recalled
9

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 25, 2016 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.