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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 March 12, 2018
Create Date August 31, 2018
Recall Status1 Terminated 3 on November 23, 2021
Recall Number Z-2968-2018
Recall Event ID 80723
510(K)Number K131497  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product McKesson Cardiology Hemo, Release SW version 13.0.
Used for physiological monitoring, image and data processing.

McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.
Code Information software versions: 13.0 HF1, 13.0HF2, 13.0HF3
Recalling Firm/
Manufacturer		 McKesson Israel Ltd.
Or Towers Bldg. B
4, Nehoshet St.
Tel Aviv Israel
Manufacturer Reason
for Recall		 Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
FDA Determined
Cause 2		 Software Design Change
Action The firm, Change Healthcare Israel Ltd., sent an "Urgent Field Safety Notice" dated on 03/12/2018 to its customers. The notice explained the product, issue and actions to be taken. The customers were instructed to: distribute the notice to all those within your organization who need to be aware; alert other parties affiliated with your organization, which are affected by this field safety notice; and maintain awareness of this notice and resulting action until the defect has been corrected, to ensure effectiveness of the corrective action. Change Healthcare has developed software updates to address the problem. If you have any questions, contact Change Healthcare Customer Support (US) 1-800-654-4366 or (UK) 440(0) 208-952-799 to arrange for the installation of software update/upgrade.
Quantity in Commerce 31 units
Distribution US Distribution to states of: CA, CO, CT, FL, GA, KS, IN, LA, NJ, NY, OK, OH, SC, and TX; and internationally to: UK.
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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