FDA-Device2021-03-24Class II
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
Mindray DS USA, Inc. dba Mindray North America
Hazard
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
Sold states
Nationwide Canada
Affected count
1938 systems
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1254-2021Don't want to check this manually?
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