# FDA recall Z-0847-2018

> **Mindray DS USA, Inc. dba Mindray North America** · Class II · device recall initiated 2017-07-14.

## Product

A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7)      Product Usage:  The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.

## Reason for recall

A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.

## Distribution

Worldwide Distribution - US Nationwide

## Key facts

- **Recall number:** Z-0847-2018
- **Recalling firm:** Mindray DS USA, Inc. dba Mindray North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-14
- **Report date:** 2018-03-14
- **Termination date:** 2019-04-17

- **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-0847-2018

## Citation

> AI Analytics. FDA recall Z-0847-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0847-2018. Source: US FDA. Licensed CC0.

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