Class III — Mindray DS USA, Inc. dba Mindray North America
| Recalling firm | Mindray DS USA, Inc. |
|---|---|
| Registered facility | MINDRAY DS USA, Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification. |
| 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. |
| Quantity | 1719 |
| 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. |
| Initiated | 2017-12-01 |
| Classified | 2018-03-28 |
| Terminated | 2018-08-29 |
| Recall number | Z-1242-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Mindray DS USA, Inc. dba Mindray North America (Z-1242-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79423/
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