Z-1688-2015Class II

Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo Advanced Perfusion System 1 is indicated for...

Name: Z-1688-2015 Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo Advanced Perfusion System 1 is indicated for...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2015-05-01
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2015-05-01 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of 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... on 2015-05-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1688-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-01
Posted: 2015-05-28
Terminated: 2018-09-28
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
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
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Catalog number: 801764 and All serial number units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1688-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1687-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-28
Z-1688-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-28

Product code DTQ

K022947Class IIAdvanced Perfusion System 1 (100/120 Volt),advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 InchTerumo Cardiovascular Systems Corp. / cleared 2003-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)