Terumo Cardiovascular Systems Corporation recalls 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for…

Recall date

May 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1687-2015

FDA classification

Class II

Brand / firm

Terumo Cardiovascular Systems Corporation

Sold / distributed

Worldwide Distribution-US (nationwide) including DC and the states of AL , AR , AZ , CA , CO , CT , DE , FL , GA , HI , IA , ID , IL , IN , KY , LA , MA , MD , ME , MI , MN , MO , MS , MT , NC , ND , NE , NJ , NM , NV , NY , OH , OK , OR , PA , SC , TN , TX , UT , VA , VT , WA , WI , and WV, and th…

Why it was recalled

Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased approach beginning late 2015: - Implementing design changes and upgrades to improve the reliability of power switching and battery backup. - Adding a switch protector to the On/Off power switch to preven

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.