Z-0493-2007

Terumo Advanced Perfusion System 1; CAPIOX Control Module; Catalog number 811113 (Not distributed within the...

Name: Z-0493-2007 Terumo Advanced Perfusion System 1; CAPIOX Control Module; Catalog number 811113 (Not distributed within the...
Creator: Terumo Cardiovascular Systems Corp
Published: 2006-10-16
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2006-10-16 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1; CAPIOX Control Module; Catalog number 811113 (Not distributed within the United States) on 2006-10-16. The reason FDA records is "The pump may lose communication with the central control monitor, causing the monitor to display a service message "System Computer Needs Service" and to become non-operational". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0493-2007
Status: Terminated
Initiated: 2006-10-16
Posted: 2007-02-14
Terminated: 2009-07-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1; CAPIOX Control Module; Catalog number 811113 (Not distributed within the United States).
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The pump may lose communication with the central control monitor, causing the monitor to display a service message "System Computer Needs Service" and to become non-operational.
FDA root cause: Other
Action: Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.
Quantity in commerce: 50
Distribution: Worldwide distribution --- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Product codes and lots: Serial numbers 0006 through 0055.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)