Recall Z-2634-2017— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-2634-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-28

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2017-04-28, terminated 2019-03-22. It names one FDA 510(k) clearance: K152902. Product: TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.. Reason: Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated..

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2017-04-28
Terminated: 2019-03-22
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K152902 — Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·cleared 2016-02-18

K-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

TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.

Reason for recall

Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.

Data sourced from openFDA. This site is unofficial and independent of the FDA.