Z-2178-2012Class II

System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal...

Name: Z-2178-2012 System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-07-26
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-07-26 / Terminated / root cause: design

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 in extracorporeal circulation of blood for arterial perfusion, regional... on 2012-07-26. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined...". 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-2178-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-26
Posted: 2012-08-09
Terminated: 2012-11-16
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS re
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 26, 2012 to its customers. The letter described the product, problem and actions to be taken. To customers were instructed to review this Medical Device Recall notice and addendum; assure that all users are aware of this notice and addendum; place the addendum in the front of Section 7: Modules (p 7.1) and confirm receipt of this communication by faxing the attached Customer Response Form to the fax number/email address indicated on form. Terumo CVS is issuing a Safety Advisory to alert all Terumo System 1 users of the potential for failure and providing an addendum for the Operator Manual with instruction on how to respond to the failure. If you have any question or concerns contact Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours are Monday-Friday, 8AM - 6PM ET.
Quantity in commerce: 649 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Japan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, 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, 1100-1434, 1436, 1440, and 1441.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2178-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2177-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09
Z-2178-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09

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)