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.
FDA Recall Z-1688-2015 · Posted 2015-05-28
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2015-05-01
Date Terminated2018-09-28
Product Quantity1713 units total
Reason for Recall
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
Firm Action
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
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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