Recall Z-0321-2017— Mindray DS USA, Inc. dba Mindray North America
Class II · Terminated
Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2016-09-08, terminated 2017-05-04. It names one FDA 510(k) clearance: K150632. Product: 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. Reason: 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..
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-08
- Terminated
- 2017-05-04
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.