Z-1224-2009

Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI...

Name: Z-1224-2009 Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2009-01-12
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2009-01-12 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802100. The Central Control Monitor... on 2009-01-12. The reason FDA records is "The monitor may exhibit start-up failure, video/display issues, calibration issues, and partial or complete loss of functionality during use". 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-1224-2009
Status: Terminated
Initiated: 2009-01-12
Posted: 2009-05-29
Terminated: 2009-07-14
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802100. The Central Control Monitor (CCM) provides a centralized display of system information and on-screen control of all system devices. The CCM combines an embedded computer, a touchscreen, and a graphical user interface.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The monitor may exhibit start-up failure, video/display issues, calibration issues, and partial or complete loss of functionality during use.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified via an Urgent Medical Device Correction: Safety Advisory letter dated 1/12/09 advised of the reason for the correction, potential problems, and provided clinical information should the problem(s) arise. Customers are to review the notice, assure that all users are aware of the notice, and confirm receipt of the communication by completing the attached Customer Response Form and faxing it to the number indicated on the form. Questions or concerns should be directed to Terumo CVS Customer Service at 1-800-521-2818.
Quantity in commerce: 951
Distribution: Worldwide Distribution -- USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, 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, and Viet Nam.
Product codes and lots: Serial numbers 0020 through 0980.

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)