Z-1968-2013Class II

Terumo Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo Advanced Perfusion...

Name: Z-1968-2013 Terumo Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo Advanced Perfusion...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2013-07-26
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2013-07-26 / Terminated / root cause: software

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal... on 2013-07-26. FDA classified it as Class II and gives the reason as "The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1968-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-26
Posted: 2013-08-14
Terminated: 2017-02-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 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: The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.
Root cause tag: software
FDA root cause: Software design
Action: Terumo CVS, sent an URGENT MEDICAL DEVICE RECALL notification letter dated July 26, 2013, to all affected customers explaining the correction to the operators manual, potential hazards and what to do in response to the issue. If you have any questions or concern please contact Terumo CVS Customer Service 1-800-521-2818 Recall Fax 1-734-741-6149 Customer Service Hours: Monday Friday, 8 AM - 6 PM ET
Quantity in commerce: 1657
Distribution: Worldwide Distribution - USA (nationwide) including the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South Korea, Manila and Canada.
Product codes and lots: Catalog number: 801763

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1968-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1968-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-14
Z-1969-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-14

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)