FDA-Device2016-11-09Class II

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

Mindray DS USA, Inc. dba Mindray North America
Hazard

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.

Sold states
US and Canada
Affected count
1,278 units
Manufactured in
800 Macarthur Blvd, Mahwah, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0321-2017

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