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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Cardiology ECG Management

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  Class 2 Device Recall McKesson Cardiology ECG Management see related information
Date Initiated by Firm December 19, 2014
Date Posted January 05, 2015
Recall Status1 Terminated 3 on February 25, 2016
Recall Number Z-0910-2015
Recall Event ID 70144
510(K)Number K113515  
Product Classification Computer, diagnostic, programmable - Product Code DQK
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.
Code Information MC13.1 and MC13.1.1
Recalling Firm/
Manufacturer		 McKesson Israel Ltd.
4 Nehoshet St., or Towers
Bldg. B
Tel Aviv Israel
For Additional Information Contact Paul Sumner
404-338-3556
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 9
Distribution Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = MCKESSON ISRAEL LTD.
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