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.
Recall
- Recall Number
- Z-0910-2015
- Event Number
- 70144
- Firm
- McKesson Israel Ltd. 4 Nehoshet St., or Towers Bldg. B Tel Aviv Israel
- FEI Number
- 3007784465
- Product Code
- DQK
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- December 19, 2014
- Posted
- January 5, 2015
- Terminated
- February 25, 2016
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.
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.
McKesson sent an Urgent Field Safety Notice dated December 16, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed how to identify the potentially affected procedures and update the procedure date (if relevant) until a software update is made advailable for installation by McKesson. McKesson will proactively identify prior procedures affected by this issue and will notify customers of any issues identified. In addition to the Field Safety Notice, McKesson Israel will provide correction to the affected SW versions and will contact customers for deployment of a software patch that prevents this scenario from occurring. Customers with questions should contact McKesson Support at 1-866-777-0202. For questions regarding this recall call 404-338-3556.
Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
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