Recall Z-1254-2021 ยท MSX System, Network And Communication, Physiological Monitors
Mindray DS USA, Inc. dba Mindray North America
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
| Date | Feb 22, 2021 |
| Status | Open, Classified |
| 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 |
| Root cause | Software design |
| Action | 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 Mi |
| Quantity | 1938 systems |
| Distribution | Nationwide Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193391 | BeneVision Central Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., May 21, 2020 |