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Class 2 Device Recall Mindray V21 |
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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
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Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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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
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For Additional Information Contact |
Ms. Diane Arpino 201-995-8407
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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.
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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
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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 = MHX and Original Applicant = MINDRAY DS USA, INC.
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