Recall – Patient monitoring system intermittently freezes

Company: Mindray DS USA, Inc. dba Mindray North America
Date of Enforcement Report: 3/24/2021
Class II

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

Recall Number: Z-1254-2021

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/MANUFACTURER

Mindray North America on 2/22/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1938

DISTRIBUTION

U.S. Nationwide and International

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