Z-1286-06

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

Name: Z-1286-06 Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required)...
Creator: Terumo Cardiovascular Systems Corp
Published: 2005-10-19
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2005-10-19 / 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); Models 801763 and 801763 (Japan unit) on 2005-10-19. The reason FDA records is "While on battery power, the system may flash a low battery warning even though the battery is adequately charged". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1286-06
Status: Terminated
Initiated: 2005-10-19
Posted: 2006-07-27
Terminated: 2008-06-19
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); Models 801763 and 801763 (Japan unit).
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: While on battery power, the system may flash a low battery warning even though the battery is adequately charged.
FDA root cause: Other
Action: Customers were notified via letter dated October 19, 2005 that the Power Manager Software would be upgraded within the next six months. As of 7/7/06 all units within the U.S. have been completed and international units are still in the process of being upgraded.
Quantity in commerce: 329
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: All units using Power Manager software version 1.10 which includes serial numbers 11 through 339.

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)