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Class 2 Device Recall Horizon Cardiology Hemo Component Schiller Argus Pro PB1000 Monitor unit |
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Date Initiated by Firm |
April 15, 2010 |
Date Posted |
July 09, 2010 |
Recall Status1 |
Terminated 3 on July 21, 2010 |
Recall Number |
Z-1974-2010 |
Recall Event ID |
55598 |
510(K)Number |
K050561
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Product Classification |
computer, diagnostic, programmable - Product Code DQK
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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.
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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 NJ 07054-4506
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For Additional Information Contact |
Nir Sheep 973-355-9900
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = DQK and Original Applicant = MEDCON LTD.
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