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U.S. Department of Health and Human Services

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 Class 2 Recall
Mindray		see related information
Date Posted December 17, 2012
Recall Number Z-0528-2013
Product Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
Code Information V Series Monitor P/N's 0998-00-1800-101 and 0998-00-1800- 201.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah, New Jersey 07430
For Additional Information Contact Diana Arpino
201-995-8407
Reason for
Recall		 Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.
Action Mindray issued an "Urgent: V Series Monitoring System Corrective Action" letter dated 9/24/2012 via certified mail with return receipt verification to all hospitals. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 to arrange for relplacement of the affected product. For questions regarding this recall call 201-995-8407.
Quantity in Commerce 206 units (180 units domestic, 26 units foreign)
Distribution Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia.
 
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