08

Mar

2012

Cl ll MIndray V Series Monitor

0

Company:Mindray DS USA, Inc. d.b.a. Mindray North America
Date of Enforcement Report 3/7/12
Class ll:

PRODUCT
V Series Monitor. The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis Arrhythmia Detection Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) Cardiac Output (CO) Respiratory Gasses Respiration Rate Temperature The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. 510 K – K102004 P/N. Recall # Z-1102-2012

REASON
A system database corruption may occur that causes the V Series Monitor to reset.

RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ, by letters dated October 14, 2011 on October 17, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
542 units National; 153 units Internationally

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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