FDAFebruary 22, 2021device
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 recall recorded by the U.S. Food & Drug Administration.
The 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
What to do
FDA enforcement status: Ongoing
Brands named
mindray ds usa inc dba mindray north americamindraymindray ds
UPCs
1150512090021150344140011503441300
Recall history
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