Z-1267-06

Terumo Advanced Perfusion System 1 Large Roller Pump; Model 801041

Name: Z-1267-06 Terumo Advanced Perfusion System 1 Large Roller Pump; Model 801041
Creator: Terumo Cardiovascular Systems Corp
Published: 2005-09-01
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2005-09-01 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1 Large Roller Pump; Model 801041 on 2005-09-01. The reason FDA records is "The pump may stop during the autodose delivery without completion of the dose delivery to the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1267-06
Status: Terminated
Initiated: 2005-09-01
Posted: 2006-07-27
Terminated: 2008-06-11
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 Large Roller Pump; Model 801041.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The pump may stop during the autodose delivery without completion of the dose delivery to the patient.
FDA root cause: Other
Action: Service technicians were notified on 9/30/05 to upgrade the software on these units by March 31, 2006 as follows: pump software to version 1.20, power manager software to version 1.20 and monitor software to version 2.2.1. U.S. software has all been upgraded and international upgrades are ongoing as of 7/7/06.
Quantity in commerce: 1898 combined
Distribution: Nationwide, and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand, Turkey and United Arab Emirates.
Product codes and lots: Serial numbers 0033 through 1339.

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)