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Analytical Industries Inc.
ANALYTICAL INDUSTRIES INC. · Model PSR-11-915-G · UDI-DI 00897772002253
CCL
Prescription
1
510(k) clearances
72
Adverse events (9 deaths)
5
Recalls
82
Facilities
Description
Oxygen Sensor
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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Get your free API keyRead the docsData 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.