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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Cardiology Hemo Component Schiller Argus Pro PB1000 Monitor unit

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 Class 2 Recall
Horizon Cardiology Hemo Component Schiller Argus Pro PB1000 Monitor unit
see related information
Date Posted July 09, 2010
Recall Status1 Terminated on July 21, 2010
Recall Number Z-1974-2010
Recall Event ID 55598
Premarket Notification
510(K) Number
K050561 
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
Product Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M. A programmable diagnostic computer intended for acquiring, digitizing, storing, displaying and reviewing hemodynamic data for use in hospital cardiac catheterization laboratories. The system is cleared for us with a component physiological data collection unit - the Schiller Argus Pro PB 1000 Monitor unit.
Code Information Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M Serial numbers prefaced with PB-1000: 765.001471, 760.001566, 760.001793, 760.001882, 760.001920, 760.001934, 760.001970, 760.002043, 760.002113, 765.001168, 765.001307, 765.001520, 765.001553, 765.001599, 765.001609, 765.001510, 765.001632, 765.00165, 765.003014, 760.001320, 760,001552, 760.001555, 760,001920, 760.002107, 765.001224, 765.001306, 765.001608.
Recalling Firm/
Manufacturer
McKesson Provider Technologies - Medical Imaging Group
1639 State Rt 10 Ste 100
Parsippany, New Jersey 07054-4506
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Nir Sheep
973-355-9900
Manufacturer Reason
for Recall
McKesson has recently discovered that certain Horizon Cardiology Hemo systems were running specific Schiller Argus-Pro PB 1000 firmware versions that might cause a delay in the display of physiological parameters on the Horizon Cariology Hemo Real Time Monitor Screen.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
Action The firm, McKesson, sent an "Advisory Notice" letter dated April 15, 2010, to all customers. The letter describes the problem, products affected, and actions to be taken by customers. The customers were instructed not to use the Emergency Replacement Hemo kit until they receive a replacement Schiller Argus Pro PB-1000 and they have contacted McKesson Support department at 1-866-777-0202. If you have any questions regarding this notice, please call our Customer Support department at 1-0866-777-0202 and ask to speak to your support Manager.
Quantity in Commerce 26 units; 19 in operational use, 8 as emergency replacement units.
Distribution Nationwide distribution: CA, CO, MD, NH, NT, NY, TN, and TX .
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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