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U.S. Department of Health and Human Services

Class 2 Device Recall Mindray V21

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  Class 2 Device Recall Mindray V21 see related information
Date Initiated by Firm July 31, 2014
Date Posted October 21, 2014
Recall Status1 Terminated 3 on April 20, 2017
Recall Number Z-0107-2015
Recall Event ID 69260
510(K)Number K132026  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1

The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart Rate, Pulse Oximetry (Sp)s), ST Segment Analysis, Arrhythmia Detection, Non Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Cardia Output (CO), Respiratory Gases, Respiration Rate and Temperature.
Code Information V-Series Monitoring System, P/N: 0998-00-1800-101, 0998-00-1800-201 and DA6KB-CTO-S01.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 MacArthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Ms. Diane Arpino
201-995-8407
Manufacturer Reason
for Recall		 Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function.
FDA Determined
Cause 2		 Software design
Action Mindray DS USA, Inc. sent a Recall Correction Action Letter to their customers via certified mail with return receipt on July 31, 2014.
Quantity in Commerce 2,247 units
Distribution Worldwide Distribution: US (nationwide) and internationally to: Austalia, Canada, Columbia, Germany, India, Indonesia, Ireland, Israel, Kuwait, Malaysia, New Zealand, Pakistan, Russian Federation, Saudi Arabia, South Africa, Sri Lanka, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezula.
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 = MHX and Original Applicant = MINDRAY DS USA, INC.
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