# FDA recall Z-1242-2018

> **Mindray DS USA, Inc. dba Mindray North America** · Class III · device recall initiated 2017-12-01.

## Product

Gas Module 3 monitoring spirometer, Part Number: 115-030108-00    Product Usage:  The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.

## Reason for recall

The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.

## Distribution

Worldwide Distribution - U.S. Nationwide in the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY, including Puerto Rico and distributed to 30 foreign consignees.

## Key facts

- **Recall number:** Z-1242-2018
- **Recalling firm:** Mindray DS USA, Inc. dba Mindray North America
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-01
- **Report date:** 2018-04-04
- **Termination date:** 2018-08-29

- **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-1242-2018

## Citation

> AI Analytics. FDA recall Z-1242-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1242-2018. Source: US FDA. Licensed CC0.

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