Mindray BeneVision Distributed Monitoring System — Class II medical device recall Z-1254-2021
Ongoing recall by Mindray DS USA, Inc. dba Mindray North America, reported 2021-03-24, distributed nationwide. BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If
| Recall number | Z-1254-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2021-02-22 |
| Classified | 2021-03-15 |
| Reported by FDA | 2021-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,938 systems |
| Serial numbers | EHL58000238, EHL58000239, EHL58000240, EHL58000241, EHL58000243, EHL58000244, EHL58000245, EHL58000246, EHL58000247, EHL58000248, EHL58000249, EHL58000251, EHL58000253, EHL58000254, EHL58000255, EHL58000257, EHL58000258, EHL59000366, EHL59000367, EHL59000369, EHL59000370, EHL59000371, EHL59000372, EHL59000373, EHL59000374 and 475 more |
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 for recall
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.