Z-1978-2013Class II

220/240V AC, Advanced Perfusion System 1

Name: Z-1978-2013 220/240V AC, Advanced Perfusion System 1
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 220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for... on 2013-07-26. FDA classified it as Class II and gives the reason as "TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm...". 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-1978-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-26
Posted: 2013-08-15
Terminated: 2017-02-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 220/240V AC, Advanced Perfusion System 1 Product Usage: 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 TM or similar equipment.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system.
Root cause tag: software
FDA root cause: Software design
Action: Terumo sent an Urgent Medical Device Recall notification letter dated July 26, 2013 to all affected customers. The letter identified the affected product, reason for correction, potential hazards of the recall issue, the correction to be implemented, and customer instructions for replying to the recall notification. Terumo CVS is providing an addendum to be placed in the Operator's Manual at the beginning of Chapter 7, Modules. Questions or concerns are directed to Terumo CVS Customer Service at 1-800-521-2818, Recall Fax 1-877-275-6860. Customer Service hours are Monday to Friday 8am-6pm ET.
Quantity in commerce: 1657
Distribution: Worldwide Distribution - US Nationwide in the states of :AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MSMT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and countries of AUSTRALIA, UNITED ARAB EMIRATES (UAE),Hong Kong,Indonesia, Singapore, Taiwan, Thailand,Philippines, CHILE,Malaysia, South Korea, BELGIUM,Japan,Mexico,CANADA
Product codes and lots: Catalog number: 801764

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1978-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1977-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-15
Z-1978-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-15

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)