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
Product summary
- 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
software error