Device Recall Aespire, Aestiva, Aisys, Avance, Anesthesia device service kits

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Anesthesiology Devices

2

No

Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.

Anesthesia device service kits. || ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 || ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 || ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 || ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 || ASSY-MSN, VLV ASSY DR GAS CHK BCG, Manufacturing assembly - Buy || 1503-3006-000 || Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected and could have been installed on Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2 Anesthesia, and Amingo devices. (Service kit part numbers: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000, 1503-8101-000).