FDA Device recall Z-1242-2018
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor a…
- FDA Device
- Class III
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class III recall of Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor a… by Mindray Ds Usa, citing the firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1242-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-12-01 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mindray Ds Usa |
| Distribution | US |
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
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Identifiers
| code_info | All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1242-2018%22
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