Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Macedonia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Lote

Model Number, UDI Number, (Serial Number): 1011-9050-000, 010084068210229221APWX0132811180608, (APWX01328); 1011-9050-000, 010084068210229221APWX0048411180208, (APWX00484); 1011-9050-000, 010084068210229221APWW0214911171214, (APWW02149); 1011-9050-000, 10084068210229221APWW0215011171214, (APWW02150); 1011-9050-000, 010084068210229221APWX0026111180118, (APWX00261); 1011-9050-000, 010084068210229221APWX0026211180118, (APWX00262); 1011-9050-000, 010084068210229221APWX0140911180618, (APWX01409); 1011-9050-000, 010084068210229221APWX0141011180618, (APWX01410); 1011-9050-000, 010084068210229221APWX0141111180618, (APWX01411); 1011-9050-000, 010084068210229221APWX0141211180618, (APWX01412); 1011-9050-000, 010084068210229221APWX0141311180618, (APWX01413); 1011-9050-000, 010084068210229221APWX0141411180618, (APWX01414); 1011-9050-000, 010084068210229221APWX0141511180618, (APWX01415); 1011-9050-000, 010084068210229221APWX0141611180618, (APWX01416); 1011-9050-000, 010084068210229221APWX0141711180618, (APWX01417); 1011-9050-000, 010084068210229221APWX0141811180618, (APWX01418); 1011-9050-000, 010084068210229221APWX0141911180618, (APWX01419); 1011-9050-000, 010084068210229221APWX0142011180618, (APWX01420); 1011-9050-000, 010084068210229221APWX0142111180618, (APWX01421); 1011-9050-000, 010084068210229221APWX0142211180618, (APWX01422); 1011-9050-000, 010084068210229221APWX0026311180118, (APWX00263); 1011-9050-000, 010084068210229221APWX0026411180118, (APWX00264); 1011-9050-000, 010084068210229221APWX0026511180118, (APWX00265); 1011-9050-000, 010084068210229221APWW0214011171214, (APWW02140); 1011-9050-000, 010084068210229221APWW0215611171214, (APWW02156); 1011-9050-000, 010084068210229221APWW0215711171214, (APWW02157); 1011-9050-000, 010084068210229221APWX0158911180703, (APWX01589); 1011-9050-000, 010084068210229221APWX0159011180703, (APWX01590); 1011-9050-000, 010084068210229221APWX0159111180703, (APWX01591); 1011-9050-000, 010084068210229221APWX0159211180703, (APWX01592); 1011-9050-000, 010084068210229221APWX0159311180703, (APWX01593); 1011-9050-000, 010084068210229221APWX0159411180703, (APWX01594); 1011-9050-000, 010084068210229221APWW0146411170823, (APWW01464); 1011-9050-000, 10084068210229221APWW0162511170927, (APWW01625); 1011-9050-000, 10084068210229221APWW0162611170927, (APWW01626); 1011-9050-000, 10084068210229221APWW0162811170927, (APWW01628); 1011-9050-000, 10084068210229221APWW0208811171206, (APWW02088); 1011-9050-000, 10084068210229221APWW0208911171206, (APWW02089); 1011-9050-000, 10084068210229221APWW0209011171206, (APWW02090); 1011-9050-000, 10084068210229221APWW0209111171212, (APWW02091); 1011-9050-000, 10084068210229221APWW0209211171212, (APWW02092); 1011-9050-000, 10084068210229221APWW0209311171212, (APWW02093); 1011-9050-000, 10084068210229221APWW0209411171212, (APWW02094); 1011-9050-000, 10084068210229221APWW0209511171212, (APWW02095); 1011-9050-000, 10084068210229221APWW0209611171212, (APWW02096); 1011-9050-000, 10084068210229221APWW0209711171212, (APWW02097); 1011-9050-000, 10084068210229221APWW0209811171212, (APWW02098); 1011-9050-000, 10084068210229221APWW0209911171212, (APWW02099); 1011-9050-000, 10084068210229221APWW0210011171212, (APWW02100); 1011-9050-000, 10084068210229221APWW0210111171212, (APWW02101); 1011-9050-000, 10084068210229221APWW0210211171212, (APWW02102); 1011-9050-000, 10084068210229221APWW0210311171212, (APWW02103); 1011-9050-000, 010084068210229221APWX0086711180328, (APWX00867); 1011-9050-000, 010084068210229221APWX0086811180328, (APWX00868); 1011-9050-000, 010084068210229221APWX0086911180328, (APWX00869); 1011-9050-000, 010084068210229221APWX0087011180328, (APWX00870); 1011-9050-000, 010084068210229221APWX0087111180328, (APWX00871); 1011-9050-000, 010084068210229221APWX0087211180328, (APWX00872); 1011-9050-000, 010084068210229221APWX0036911180131, (APWX00369); 1011-9050-000, 010084068210229221APWX0143411180618, (APWX01434);

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States