FDA-Device2012-10-17Class II
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Terumo Cardiovascular Systems Corporation
Hazard
Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In
Sold states
Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, UT, VA, WA, WI, and WV. Puerto Rico and internationally to: ALEXANDRIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CENTRO AMERICA, CHILE, COLOMBIA, Dominican Republic, Ecuador, FRANCE, GERMANY, GREECE, Guatamala, HOLLAND, HONG KONG, India, ITALY, Japan, KL SEGUNDO, KOREA, LEICESTERSHIRE, MALAYSA, Malaysia, Mexico, Mexico, Mexico, NETHERLANDS, Panama, Peru, Philippines, RALEIGH, Republic of Georgia, SANTIAGO CHILE, Saudi Arabia, SEOUL KOREA, SHANGHAI, CHINA, Singapore, South Africa, SPAIN, SWITZERLAND, TAIWAN, Thailand, UNITED ARAB EMIRATES (UAE), Uruguay, USA, and Venezuela,
Affected count
289 units
Manufactured in
6200 Jackson Road, N/A, Ann Arbor, MI, United States
Products
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0050-2013Don't want to check this manually?
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