O2-Sensor

IT Dr. Gambert GmbH · Model M-12 · UDI-DI 04250320600282

CCL Prescription

510(k) clearances

Adverse events (9 deaths)

Recalls

Facilities

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(Ai)O(V)(X) and Card
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, the Airway Gas Opt
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 pump failure that may
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 result in interrupted tre
2003-10-27	Teledyne Analytical Instruments	Potential failure to display the battery low light to the end-user.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.