FDA recall Z-0554-2018

Mindray DS USA, Inc. dba Mindray North America · Class II · device

Product

TD60 Transmitter battery charger used with the BeneVision Central Station, 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.

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.

Key facts

Status: Terminated
Initiation date: 2017-07-14
Report date: 2018-02-14
Termination date: 2018-12-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0554-2018