Recall Z-2108-2021— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-2108-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-27

Class III · Terminated

Class III FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2021-05-27, terminated 2022-08-11. It names one FDA 510(k) clearance: K193391. Product: 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.. Reason: Telepack may not power on when using the 3AA battery cradle..

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class III
Status: Terminated
Initiated: 2021-05-27
Terminated: 2022-08-11
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K193391 — BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.·cleared 2020-05-21

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

3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.

Reason for recall

Telepack may not power on when using the 3AA battery cradle.

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