Z-0432-2007

Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required)...

Name: Z-0432-2007 Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required)...
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; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763 on 2006-10-16. The reason FDA records is "A 'battery needs service' message may be displayed, or the remaining battery time may incorrectly be reported out as zero, even when the battery is fully functional". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0432-2007
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; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: A 'battery needs service' message may be displayed, or the remaining battery time may incorrectly be reported out as zero, even when the battery is fully functional.
FDA root cause: Other
Action: Consignees were sent a letter dated 11/10/06 informing them of the nature of the issues and that the firm would contact them to schedule a service call to install the software upgrade package. The software upgrade installation began at customers on 10/16/06, prior to issuance of the letter to consignees.
Quantity in commerce: 489
Distribution: Worldwide distribution ---- including USA and countries 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 0011 through 0039 and 0041 through 0500.

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)