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U.S. Department of Health and Human Services

Class 2 Device Recall 100/120V AC, Advanced Perfusion System Platform (APS)

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 Class 2 Device Recall 100/120V AC, Advanced Perfusion System Platform (APS)see related information
Date Initiated by FirmMay 01, 2015
Date PostedMay 28, 2015
Recall Status1 Terminated 3 on September 28, 2018
Recall NumberZ-1688-2015
Recall Event ID 67989
510(K)NumberK022947 
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
ProductBase 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.
Code Information Catalog number: 801764 and All serial number units
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer 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
FDA Determined
Cause 2
Device Design
ActionOn 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
Quantity in Commerce1713 units total
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DTQ
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