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Terminated

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

FDA Recall Z-0321-2017 · Posted None

Recalling FirmMindray DS USA, Inc. dba Mindray North America
Recall StatusTerminated
Product CodeMHX
Date Initiated2016-09-08
Date Terminated2017-05-04
Product Quantity1,278 units

Reason for Recall

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.

Firm Action

Mindray sent a "Medical Device Action" letter dated September 8, 2016 via UPS to their affected customers.

Root Cause

Device Design

Distribution Pattern

US and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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