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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Cardiology Hemo

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  Class 2 Device Recall McKesson Cardiology Hemo see related information
Date Initiated by Firm June 25, 2014
Date Posted October 20, 2014
Recall Status1 Terminated 3 on October 26, 2017
Recall Number Z-0093-2015
Recall Event ID 69380
510(K)Number K131497  
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
Product McKesson Cardiology Hemo.

McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Code Information McKesson Cardiology TM Hemo versions: 11.0HF5, 11.1, 11.1SP5, 11.1SP6, 11.1SP6HF1, 11.1SP6HF3, 12SP1, 12.1, 12.1HF1, 12.1HF2, 12.2, 12.2HF1, 12.2HF2, 12.2HF3, 12.2HF4.
Recalling Firm/
Manufacturer		 Mckesson Information Solutions LLC
5995 Winward Plaza
Information Technology Business
Alpharetta GA 30005
For Additional Information Contact Paul Sumner
404-338-3556
Manufacturer Reason
for Recall		 McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker i
FDA Determined
Cause 2		 Labeling design
Action Consignees were notified via Field Safety Notice on 06/25/2014.
Quantity in Commerce 625 devices
Distribution Worldwide Distribution-USA (nationwide) and the countries of Australia, Botswana, Canada, Germany, New Zealand, Netherlands, Pakistan, Portugal, South Africa, Turkey and 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 = MWI and Original Applicant = MCKESSON ISRAEL LTD.
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