Recall Z-0321-2017 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China
| Date | Sep 8, 2016 |
| Status | Terminated |
| Reason | Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Central Station may crack on the bezel surrounding the display and also the transmitter may not power on or will power on but display an error message. |
| Root cause | Device Design |
| Action | Mindray sent a "Medical Device Action" letter dated September 8, 2016 via UPS to their affected customers. |
| Quantity | 1,278 units |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150632 | Hypervisor IX Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Jul 6, 2015 |