Recall Z-0554-2018

Mindray DS USA, Inc. dba Mindray North America · initiated July 14, 2017

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00

Codes / lots: All battery chargers with part number 115-030108-00

Reason for recall

A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.

FDA-determined cause: Component design/selection

Action taken

Certified letters were sent to all affected customers on 07/14/2017, to offer a replacement of the battery charger.

Details

Recall number
Z-0554-2018
Initiated
July 14, 2017
Terminated
December 17, 2018
Product code
MSX – System, Network And Communication, Physiological Monitors
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.
Recalling firm
Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ

Official FDA recall record