FDAFDA · Food and drugs·Recall number Z-1688-2015
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.
Published June 3, 2015 · Recall initiated: May 1, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- 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.
- Lot
- Catalog number: 801764 and All serial number units
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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