The affected serial numbers of the CARESCAPE respiratory modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO, and their respective service exchange units are found in the list provided in the Appendix of this notification.
The affected modules could be in use with any of the following GE host devices:
- CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor
- Airway Gas Option N-CAiO modules with B40 Patient Monitor
US: CA, CO, FL, GA, IN, KY, LA, MD,MI, NY,NC,OH, PA, SC, TN, TX, VA,WI. OUS: UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, PHILIPPINES, PANAMA, PAKISTAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, MEXICO, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COLOMBIA, CHILE, BULGARIA, BELGIUM, AZERBAIJAN, AUSTRALIA.
Description du dispositif
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. || The affected modules could be in use with any of the following GE host devices: || -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor || -Airway Gas Option N-CAiO modules with B40 Patient Monitor