Z-0294-2007

Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188

Name: Z-0294-2007 Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188
Creator: Terumo Cardiovascular Systems Corp
Published: 2004-01-01
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2004-01-01 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188 on 2004-01-01. The reason FDA records is "The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0294-2007
Status: Terminated
Initiated: 2004-01-01
Posted: 2006-12-19
Terminated: 2007-02-02
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable.
FDA root cause: Other
Action: U.S. consignees were visited by firm representatives between January 2004 and September 2005 and the device modified to correct the problem. Approximately 32 exported units are still in need of being upgraded.
Quantity in commerce: 199 units
Distribution: Worldwide, including USA, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Product codes and lots: Serial numbers 00010, 00011, 00012, 00013, 00014, 00015, 00016, 00017, 00019, 00020, 00024 through 00038, 00040, 00042 through 00050, 00052 through 00063, 00065 through 00082, 00084 through 00096, 00098 through 00103, 00105 through 00123, 00125 through 00152, 00154 through 00160, 00162 through 00174, 00176 through 00197, 00199 through 00208, 00211, 00213 through 00224 and 00226.

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)