Gas Module 3 monitoring spirometer — Class III medical device recall Z-1242-2018
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2018-04-04, distributed nationwide. The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
| Recall number | Z-1242-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2017-12-01 |
| Classified | 2018-03-28 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2018-08-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,719 |
| Model numbers | 115-030108-00 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1242-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.