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.
- Recall Initiated
- December 1, 2017
- Terminated
- August 29, 2018
- Recall Number
- Z-1242-2018
- Quantity
- 1719
- Firm Location
- Mahwah, NJ
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.
Lot / Code Info
All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.
Root Cause
Device Design
Action Taken
Mindray sent an Safety Notification letter dated December 1, 2017 to all customers. The letter identified the affected product, problem and actions to be taken. For question call 201-995-8407.
More recalls by Mindray Ds Usa, Inc. D.B.A. Mindray North America
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Dis...
Dec 12, 2025
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:...
Nov 26, 2025
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:...
Nov 26, 2025