Z-0930-2007

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required)...

Name: Z-0930-2007 Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required)...
Creator: Terumo Cardiovascular Systems Corp
Published: 2005-02-01
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2005-02-01 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the... on 2005-02-01. The reason FDA records is "System 1 power supply may electrically short to the main console, disrupting normal system operation by causing unexpected re-setting or shutdown of pumps and modules, false alarms and/or overheating and failure of the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0930-2007
Status: Terminated
Initiated: 2005-02-01
Posted: 2007-06-30
Terminated: 2009-07-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: System 1 power supply may electrically short to the main console, disrupting normal system operation by causing unexpected re-setting or shutdown of pumps and modules, false alarms and/or overheating and failure of the central control monitor.
FDA root cause: Other
Action: The firm corrected the complaint units at the time of the complaints in 2005. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their system will be corrected when replacement components become available.
Quantity in commerce: 416 for both models
Distribution: Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan and Singapore.
Product codes and lots: Serial numbers 0006 through 0066, 0100 through 0144, 0146, 0147 and 0149 may be affected by this issue. Serial number 0046 have been corrected to date.

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)