Recall Z-2737-2015 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.
| Date | Sep 4, 2015 (initiated Jul 27, 2015) |
| Status | Terminated |
| Reason | The DPM 7 Monitors may display a black screen. |
| Root cause | Under Investigation by firm |
| Action | Mindray sent an Urgent Medical Device Correction / DPM 7 Monitor letter, dated July 27, 2015, to their affected customers via certified mail and return receipt. The letter identified the problem as well as the affected product, adverse effects on patients, and corrective action. The firm will repair the potentially affected monitor at no cost to the customer. Customers are to contact their Mindray Service Representative at 1-800-288-2121 to arrange for the repair. |
| Quantity | 13 units |
| Distribution | Distributed to the states of CT, IA, KY, MS, PA, UT and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092449 | BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5 Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Aug 30, 2010 |