Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module ...
FDA Device Recall #Z-1242-2018 — Class III — December 1, 2017
Recall Summary
| Recall Number | Z-1242-2018 |
| Classification | Class III — Low risk |
| Date Initiated | December 1, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mindray DS USA, Inc. dba Mindray North America |
| Location | Mahwah, NJ |
| Product Type | Devices |
| Quantity | 1719 |
Product Description
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 Pattern
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 Information
All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.
Other Recalls from Mindray DS USA, Inc. dba Mindray Nort...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0920-2026 | Class II | Hardware configuration of the BeneVision Centra... | Nov 18, 2025 |
| Z-0720-2026 | Class II | Sevoflurane (SEVO) V90 Electronic Vaporizer wit... | Oct 20, 2025 |
| Z-0721-2026 | Class II | Isoflurane (ISO) V90 Electronic Vaporizer with ... | Oct 20, 2025 |
| Z-2622-2025 | Class II | BeneVision N1 Patient Monitor (N1). Part Number... | Aug 15, 2025 |
| Z-2951-2024 | Class II | Isoflurane E_Vap.(Safety Filling adapter): used... | Jul 22, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.