Recall Z-0554-2018 ยท MSX System, Network And Communication, Physiological Monitors
Mindray DS USA, Inc. dba Mindray North America
TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
| Date | Jul 14, 2017 |
| Status | Terminated |
| Reason | A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate. |
| Root cause | Component design/selection |
| Action | Certified letters were sent to all affected customers on 07/14/2017, to offer a replacement of the battery charger. |
| Quantity | 203 |
| Distribution | Distributed in 26 states: AL, CA, CO, FL, GA, IA, IN, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, WA, and WY; and Puerto Rico. |
| 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 |