Z-0336-2007

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

Name: Z-0336-2007 Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188
Creator: Terumo Cardiovascular Systems Corp
Published: 2004-10-12
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2004-10-12 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188 on 2004-10-12. The reason FDA records is "Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0336-2007
Status: Terminated
Initiated: 2004-10-12
Posted: 2006-12-30
Terminated: 2007-02-01
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: Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
FDA root cause: Other
Action: U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.
Quantity in commerce: 4,740 for all affected products
Distribution: Worldwide Distribution-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 00010 through 00016, 00019, 00024 through 00027, 00030 through 00033, 00035, 00036, 00038 through 00040, 00042 through 00046, 00048 through 00050, 00052 through 00054, 00056 through 00059, 00061 through 00063, 00065, 00066, 00068, 00069, 00071 through 00073, 00075 through 00078, 00082, 00084, 00085, 00087, 00088, 00091, 00094, 00095, 00098 through 00103, 00105 through 00107, 00109 through 00111, 00113 through 00115, 00122, 00126 through 00129, 00133 through 00135, 00139, 00140, 00144, 00145, 00147, 00148, 00151, 00152, 00154 through 00157, 00163, 00167, 00168 through 00174, 00176 through 00182, 00184 through 00196, 00200, 00202 through 00206, 00210, 00211, 00213, 00214, 00216 through 00224, 00228 through 00231, 00237 through 00241, 00245 through 00250, 00300 through 00327 and 00330.

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)