RegWardenFDA facility compliance records
Recall

Class II — Mindray DS USA, Inc. dba Mindray North America

Recalling firmMindray DS USA, Inc.
Registered facilityMINDRAY DS USA, Inc. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonMindray 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.
ProductTD60 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
Quantity1,278 units
DistributionUS and Canada
Initiated2016-09-08
Classified2016-10-28
Terminated2017-05-04
Recall numberZ-0321-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Mindray DS USA, Inc. dba Mindray North America (Z-0321-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75062/

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