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Analyzer, Gas, Oxygen, Gaseous-Phase
FDA product code CCL · Class 2 · Anesthesiology
670
Registered devices
72
Adverse events
5
Recalls
122
510(k) clearances
Devices with this code
MOX4 — Honeywell Healthcare Solutions GmbHO2-Sensor — IT Dr. Gambert GmbHNOxBOXi — NOXBOX LTDO2-Sensor — IT Dr. Gambert GmbHMOX1 — CITY TECHNOLOGY LIMITEDMAXVENTURI — MAXTEC, LLCOxygen Sensor — Honeywell Healthcare Solutions GmbHNOxBOXi — NOXBOX LTDAnalytical Industries Inc. — ANALYTICAL INDUSTRIES INC.NA — GE Medical Systems Information Technologies, Inc.TEC-505-1AS — MAXTEC, LLCMAX-12C — MAXTEC, LLCTeledyne Analytical Instruments — Teledyne Analytical InstrsO2-Sensor — IT Dr. Gambert GmbHCARESCAPE B450 — GE Healthcare Finland OyNewport Medical — Newport Medical Instruments, Inc.Oxygen Sensor — Honeywell Healthcare Solutions GmbHMAX-7L — MAXTEC, LLCO2-Sensor — IT Dr. Gambert GmbHNA — GE Healthcare Finland OyMAXO2+ — MAXTEC, LLCISA™ OR+ — MASIMO CORPORATIONO2-Sensor — IT Dr. Gambert GmbHNA — GE Healthcare Finland Oy
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-24 | GE Healthcare | A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C |
| 2014-08-08 | GE Healthcare, LLC | GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules |
| 2014-05-23 | GE Healthcare, LLC | Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to p |
| 2009-11-25 | Teleflex Medical | Sensor causes the oxygen monitor to display prematurely a Low Sensor warning which indicates an early maintenance requirement for the instrument. This may resul |
| 2003-10-27 | Teledyne Analytical Instruments | Potential failure to display the battery low light to the end-user. |
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