FDA Device recall Z-1254-2021
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 follo…
- FDA Device
- Class II
- ongoing
- Published 2021-03-24
On 2021-03-24 the FDA classified a Class II recall of 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 follo… by Mindray Ds Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1254-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-02-22 |
| Published | 2021-03-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mindray Ds Usa |
| Distribution | US |
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
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
Identifiers
| code_info | Serial Numbers: EHT92003259 EHL5A000498 EHL61000561 EHL67000842 EHL67000843 EHM67000809 EHT04004409 EHT04004412…Serial Numbers: EHT92003259 EHL5A000498 EHL61000561 EHL67000842 EHL67000843 EHM67000809 EHT04004409 EHT04004412 EHT0A004549 EHT94003329 EHT94003338 EHT94003342 EHT96003496 EHT9C003918 EHT9C003920 EHL64000627 EHL64000629 EHL64000622 EHL65000697 EHL6B001060 EHL6B001063 EHL6B001069 EHM6C001164 EHL74001282 EHM86002739 EHL5B000545 EHL78001536 EHT07004512 EHT8A002987 EHT02004001 EHT87002783 EHT87002784 EHL5A000463 EHT04004422 EHT92003257 EHL65000729 EHM69000971 EHT89002847 EHT89002850 EHT89002860 EHT87002781 EHL75001349 EHM74001293 EHM75001343 EHL74001301 EHL78001509 EHM69000970 EHT0A004556 EHT8A002980 EHL5A000532 EHM67000801 EHT91003190 EHT99003784 EHL73001200 EHL73001205 EHL73001207 EHT94003326 EHL79001585 EHM7B001731 EHL5A000526 EHL5B000543 EHL65000717 EHL65000721 EHT96003499 EHT88002799 EHT94003339 EHT96003503 EHT9C003922 EHL83002385 EHL81002225 EHL83002304 EHL83002310 EHL74001311 EHL83002387 EHL67000845 EHL73001 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1254-2021%22
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