Is Base for Terumo Advanced Perfusion System 1, 220/240V 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. recalled?

Question

Accepted Answer

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

Status: Voluntary: Firm initiated

Initial Firm Notification: Letter

Distribution: 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 the countries of Mexico , AUSTRALIA , UNITED ARAB EMIRATES (UAE) , Hong Kong , Indonesia , Singapore , Taiwan , Thailand , Philippines , South Korea , CHILE , Vietnam , Malaysia , BELGIUM , Japan , and CANADA.

Affected Products

Additional Information

Were You Affected by This Recall?

Affected Products

Additional Information

Were You Affected by This Recall?