Z-1966-2012Class 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-1966-2012 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: 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 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 Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if...". 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-1966-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-22
Posted: 2012-07-09
Terminated: 2013-11-08
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. The System 1 base includes an integrated backup battery in the event of power loss.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use, such as would occur with a backup system. This may result in unexpected system shutdown. Prolonged battery depletion may cause permanent battery damage.
Root cause tag: design
FDA root cause: Device Design
Action: TERUMO sent an Urgent Medical Device Recall letter dated June 22, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to review the Medical Device Recall Notice, assure that all users are aware of the notice. Consignees should place the Addendum at the beginning of the System Base Section (page 3-1) of the Operator's manual, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number indicated on the form. All System 1 product is on quality hold. Terumo CVS will release product including batteries as needed only in the event that customers require service. All affected System 1 customers will receive a safety notification and an addendum to the Operator's Manual. There will be a field correction but no product returned for this recall. Customers with questions should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.
Quantity in commerce: approx. 632 units
Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to: Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam,
Product codes and lots: Catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1966-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1965-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09
Z-1966-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09

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)