ClearanceBrief
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

DateJul 14, 2017
StatusTerminated
ReasonA damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.
Root causeComponent design/selection
ActionCertified letters were sent to all affected customers on 07/14/2017, to offer a replacement of the battery charger.
Quantity203
DistributionDistributed 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 recordOpen on fda.gov

510(k) clearances named in this recall

K150632Hypervisor IX Monitoring System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Jul 6, 2015