Recall Z-0389-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) 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: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rat
| Date | Nov 25, 2013 (initiated Oct 7, 2013) |
| Status | Terminated |
| Reason | Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerning the issue. |
| Root cause | Environmental control |
| Action | Mindray sent an Urgent Corrective Action letter dated October 7, 2013 to all of their customers. The letter identified the affected product, problem and actions to be taken. Customers should contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday from 830 am to 530 pm to arrange for the replacement of the affected product. |
| Quantity | 1839 units |
| Distribution | Worldwide Distribution - USA Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102004 | ENDEAVOUR MONITORING SYSTEM Mindray DS USA, Inc., Sep 10, 2010 |