Recall Z-0742-2013 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. d.b.a. Mindray North America
Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
| Date | Jan 27, 2013 (initiated Sep 5, 2012) |
| Status | Terminated |
| Reason | Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available. |
| Root cause | Device Design |
| Action | Mindray DS USA Inc. sent an Urgent Product Corrective Action letter on September 5, 2012 via Fed Ex with delivery confirmation to all users. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday 8:30-5:30 pm, to schedule a software upgrade. |
| Quantity | 13 units |
| Distribution | US Nationwide Distribution including the states of: VA, TN, FL, & TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053234 | PM-9000 EXPRESS PATIENT MONITOR Shenzhen Mindray Bio-Medical Electronics Co., Ltd., May 4, 2006 |