| Class 2 Device Recall 100/120V AC, Advanced Perfusion System Platform (APS) | |
Date Initiated by Firm | May 01, 2015 |
Date Posted | May 28, 2015 |
Recall Status1 |
Terminated 3 on September 28, 2018 |
Recall Number | Z-1688-2015 |
Recall Event ID |
67989 |
510(K)Number | K022947 |
Product Classification |
Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
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Product | 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. |
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
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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 |
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 |
Quantity in Commerce | 1713 units total |
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. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DTQ
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