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Recall Observatory FDA recall evidence

Device product

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.

Z-0910-2015

December 19, 2014

Class II

Product summary

Firm
McKesson Israel Ltd.
Event
Event 70144
Status
Terminated
Classification
Class II
Quantity
9
Official record key
device-enforcement:Z-0910-2015

Official wording

Reason: 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.

Code information: MC13.1 and MC13.1.1

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software error