Recall Z-0910-2015 ยท DQK Computer, Diagnostic, Programmable
McKesson Israel Ltd.
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.
| Date | Jan 5, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 9 |
| Distribution | Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113515 | HORIZON CARDIOLOGY ECG MANAGEMENT Mckesson Israel , Ltd., Mar 16, 2012 |