Reported Sep 5, 2012 · Terminated
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use…
Mindray DS USA, Inc. d.b.a. Mindray North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. d.b.a. Mindray North America · 800 MacArthur Blvd. · Mahwah, NJ · 07430
Is this the product you have?
- V Series Patient Monitors; Mindray DS USA, Inc
- Product UsageThe V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following
- human physiological parametersECG waveform derived from 3, 5, 6 and 12 lead measurements; Heart Rate; Pulse Oximetry (SpO2); ST Segment Analysis; Arrhythmia Detection; Non Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Cardiac Output (CO); Respiratory Gasses; Respiration Rate; and Temperature. The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. The target populations are adult, pediatric
- and neonate with the exception ofArrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only; IV Drug Calculations for which the target population is adult only; and Cardiac Output for which the target population is adult and pediatric only
- Lot codes and dates
- V Series Monitor Part Numbers 0998-00-1800-101 and 0998-00-1800-201.
- Amount recalled
- 979 units
Where it was sold
Why it was recalled
Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31, 2010 and January 9, 2012.
This product could cause temporary or reversible health problems — stop using it.
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