FDA-Device2014-05-28Class I
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Maquet Datascope Corp - Cardiac Assist Division
Hazard
Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
Sold states
Worldwide Distribution - USA (nationwide) and approximately 104 countries.
Affected count
11,881 units (US 5183 and OUS 6698)
Manufactured in
1300 MacArthur Blvd., N/A, Mahwah, NJ, United States
Products
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1523-2014Don't want to check this manually?
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