Z-2056-2012Class II

System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the...

Name: Z-2056-2012 System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-06-22
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-06-22 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of System 1 Base 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... on 2012-06-22. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2056-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-22
Posted: 2012-07-20
Terminated: 2013-03-06
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: System 1 Base 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 Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messages and alarms; therefore it is easily recognizable by the user. The potential hazards are dependent on the application
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: TERUMO sent an Urgent Medical Device Recall letter dated June 22, 2012, and an update to the Operator's Manual via Federal Express to inform consignees of the reported malfunction and potential hazards and to raise awareness of the benefits of using a retrograde valve and the importance of backup system availability. Consignees were instructed to review the Medical Device Correction notice, assure that all users are aware of the notice. Place the Addendum at the beginning of the Centrifugal System Section of the Operator's Manual, Confirm receipt of the communication by faxing or emailing a completed Customer Response Form as indicated on the form. For any questions customers should call 1-800-521-2818.
Quantity in commerce: 640 devices
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Nationwide and worldwide: ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
Product codes and lots: catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, and 1100-1429.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2056-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2055-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-20
Z-2056-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-20

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)