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

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

Mindray issued URGENT Medical Device Correction letter on February 22, 2021 via certified mail, return receipt, signature required. Letter stated reason for recall, health risk and action to take: Should the BeneVision DMS freeze, perform a reboot of the system and normal monitoring will resume. If needed, Mindrays Technical Support team can assist and may be reached at (877) 913-9663 (Option 1), Monday through Friday, 8:30am - 5:30pm ET. A configuration change will be deployed by Mindrays Service team and is anticipated to take approximately 10-15 minutes per system. A representative from Mindrays Service team will contact you to schedule the update. The FDA requests that you acknowledge receipt of this recall by completing the attached Acknowledgement and Receipt Form. Please return the form in the stamped envelope provided, or by email to [email protected].