Recall Z-2279-2012 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. d.b.a. Mindray North America
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 S
| Date | Aug 28, 2012 (initiated May 7, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Mindray sent an Urgent: V Series Monitoring System Correction letters dated May 7, 2012 via certified mail to all affect customer. The letter identified the affected product, problem and actions to be taken. Customers are directed that VPS modules should not be used between systems until a software upgrade has been completed. This work will be done at no cost to the customer. For questions contact your Mindray Serviice Representative at 1-800-288-2121. |
| Quantity | 979 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102004 | ENDEAVOUR MONITORING SYSTEM Mindray DS USA, Inc., Sep 10, 2010 |