Z-0910-2015 Class II Terminated
FDA device recall Z-0910-2015 was initiated by McKesson Israel Ltd. on December 19, 2014 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated February 25, 2016). Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2015
- Initiation Date
- December 19, 2014
- Termination Date
- February 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product 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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
Code Information
MC13.1 and MC13.1.1