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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Cardiology Hemo Monitoring System

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 Class 2 Recall
Horizon Cardiology Hemo Monitoring System
see related information
Date Posted June 24, 2010
Recall Status1 Terminated on June 25, 2010
Recall Number Z-1899-2010
Recall Event ID 55597
Premarket Notification
510(K) Number
K050561 
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
Product Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.
Code Information Serial numbers: 2008052847, 2008072107, 2008092609, 2008092608, 2009010800, 2008121714, 2008101609, 2008101608, 2008101618, 2008110391, 2008110390, 2008110389, 2009020226, 2009020227, 2009030603, 2009030602, 2009030601, 2009110399, 2008110398, 2008051520, 2008051519, 2008051518.
Recalling Firm/
Manufacturer
McKesson Provider Technologies - Medical Imaging Group
1639 State Rt 10 Ste 100
Parsippany, New Jersey 07054-4506
For Additional Information Contact Nir Sheep
973-355-9806
Manufacturer Reason
for Recall
McKesson has identified a potential hardware configuration problem in some Horizon Cardiology Hemo systems which may cause delay and/or loss of the patient's physiological parameters on the Horizon Cardiology Hemo screen and on the patient record.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, McKesson Israel Ltd., sent notification letter dated January 27, 2010 to customers. The letter describes the product, problem and action to be taken by customers and the firm. McKesson's will be contacting the customer to coordinate replacement of the sound component of the Horizon Cardiology Hemo system and will provide the additional sound adapter for all affected systems at your facility at not cost. The customers were instructed to pleasel immediately conduct the following instructions to disable sound operations-1) Open McKesson Management Console and locate the Windsurfer>Monitor Settings; 2) Uncheck "Enable QRS beep" in the sounds section; 3) Locate Windsufer>Hardware Settings in McKesson Management Console, and 4) Uncheck "Enable QRS beep" in the Analog Output, QRS Beep Section. If you have any questions, please do not hesitate to contact Ronen Gans directly at (973) 355-9900.
Quantity in Commerce 22 devices
Distribution Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = MEDCON LTD.
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