# FDA recall Z-2622-2025

> **Mindray DS USA, Inc. dba Mindray North America** · Class II · device recall initiated 2025-08-15.

## Product

BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01    The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.

## Reason for recall

Potential for activation of an abnormal alarm pause.

## Distribution

Worldwide - Nationwide distribution and the country of Canada.

## Key facts

- **Recall number:** Z-2622-2025
- **Recalling firm:** Mindray DS USA, Inc. dba Mindray North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-15
- **Report date:** 2025-10-01

- **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-2622-2025

## Citation

> AI Analytics. FDA recall Z-2622-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2622-2025. Source: US FDA. Licensed CC0.

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