FDA-Device2015-03-25Class II
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
GE Healthcare
Hazard
Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
Sold states
Worldwide Distribution. US nationwide, ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, CANADA, CAMEROON, CANDA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, GUATEMALA, HONDURAS, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MACEDONIA, MALAYSIA, MALTA , MEXICO, MOROCCO, NETHERLANDS, OMAN, PANAMA, PAPUA NEW GUINEA, PERU, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, VENEZUELA, and URUGUAY.
Affected count
3,213 (437 US, 2,776 OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1270-2015Don't want to check this manually?
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