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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Cardiology Hemo System

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  Class 2 Device Recall McKesson Cardiology Hemo System see related information
Date Initiated by Firm August 27, 2014
Date Posted October 08, 2014
Recall Status1 Terminated 3 on May 18, 2016
Recall Number Z-0042-2015
Recall Event ID 69377
510(K)Number K131497  
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
Product McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Code Information McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1.
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		 Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action On August 27, 2014, McKesson initiated a correction via a Field Safety Notice to all affected domestic customers. McKesson Israel will be responsible for contacting foreign consignees.
Quantity in Commerce 272 devices
Distribution Worldwide distribution: US (nationwide) including states of: AR, CA, FL, DE, GA, HI, IL, IN, KS, LA, MA, MD, MN, MO, MS, MT, NJ, NV, OK, PA, SC, TNTX, , UT, WA; and countries of: Australia, Canada, Israel 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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