Z-2279-2012 Class II Terminated
FDA device recall Z-2279-2012 was initiated by Mindray DS USA, Inc. d.b.a. Mindray North America on May 7, 2012 and is designated Class II. Reason for recall: 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 Sys… The recall status is terminated (terminated July 17, 2013). Affected quantity: 979 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2012
- Initiation Date
- May 7, 2012
- Termination Date
- July 17, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 979 units
Product Description
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The 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 parameters: ECG 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 of: Arrhythmia 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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide including the states of: NY, SD, NE, IL, MO, CA, OH, OK, WA, IN, WY, CO, TX, FL, NC, AL and Puerto Rico. and the countries of: Australia, Canada, Columbia, New Zealand, Pakistan, Russia, Saudi Arabia, United Kingdom and Venezuela.
Code Information
V Series Monitor Part Numbers 0998-00-1800-101 and 0998-00-1800-201.