Recall Z-1254-2021— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-1254-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-22

Class II · Ongoing

Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2021-02-22. It names one FDA 510(k) clearance: K193391. Product: Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01. Reason: BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no longer communicate data to the BeneVision DMS.

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class II
Status: Ongoing
Initiated: 2021-02-22
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

Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01

Reason for recall

BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no longer communicate data to the BeneVision DMS

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