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.
Recall
- Recall Number
- Z-1688-2015
- Event Number
- 67989
- Firm
- Terumo Cardiovascular Systems Corporation
- FEI Number
- 1828100
- Product Code
- DTQ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 1, 2015
- Posted
- May 28, 2015
- Terminated
- September 28, 2018
- Address
- 6200 Jackson Rd, Ann Arbor, MI, 48103-9586
Description
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.
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
On 5/1/2015 Terumo issued an URGENT MEDICAL DEVICE CORRECTION letter to users explaining that Terumo has 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 prevent inadvertent shut off. - Replacing the On/Off power switch with a new design to prevent switch failure. A Terumo Field Service Representative will contact users to schedule the field correction activities once the activities are ready to be implemented. CUSTOMER INSTRUCTIONS: Review this Medical Device Correction and assure that all users have received notice of this issue. - Complete and return the enclosed Customer Response Form. - Terumo CVS will contact users to schedule the field correction activities. We encourage you to contact us with any questions or concerns: Terumo CVS Customer Service 1-800-521-2818 Fax 1-734-741-6149 Customer Service Hours: Monday Friday, 8 a.m. 6 p.m. ET
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.
1713 units total