Z-0494-2007

Terumo Advanced Perfusion System 1; Air Bubble Detection Module; Catalog number 802110

Name: Z-0494-2007 Terumo Advanced Perfusion System 1; Air Bubble Detection Module; Catalog number 802110
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; Air Bubble Detection Module; Catalog number 802110 on 2006-10-16. The reason FDA records is "The air bubble detection system may falsely continue to sound the air alarm after the user has disabled it". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0494-2007
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; Air Bubble Detection Module; Catalog number 802110.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The air bubble detection system may falsely continue to sound the air alarm after the user has disabled it.
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: 806
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 0023 through 0026, 0034, 0041, 0051, 0060, 0063 through 0065, 0067 through 0069, 0071 through 0089, 0091 through 0139, 0141 through 0242, 0246 through 0280, 0282 through 0297, 0299 through 0323, 0325 through 0393, 0395 through 0421, 0423 through 0436, 0440 through 0469, 0471 through 0530, 0532 through 0550, 0552 through 0569, 0571 through 0578, 0582 through 0661, 0664 through 0666, 0668 through 0731, 0734 through 0794, 0796 through 0807, 0813 through 0817, 0820 through 0857 and 0859 through 0896.

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)