# FDA recall Z-1254-2021

> **Mindray DS USA, Inc. dba Mindray North America** · Class II · device recall initiated 2021-02-22.

## 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

## Distribution

Nationwide  Canada

## Key facts

- **Recall number:** Z-1254-2021
- **Recalling firm:** Mindray DS USA, Inc. dba Mindray North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-22
- **Report date:** 2021-03-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1254-2021

## Citation

> AI Analytics. FDA recall Z-1254-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1254-2021. Source: US FDA. Licensed CC0.

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