Z-0279-2013Class II

Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel...

Name: Z-0279-2013 Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-10-16
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-10-16 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water... on 2012-10-16. FDA classified it as Class II and gives the reason as "Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0279-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-16
Posted: 2012-11-13
Terminated: 2013-07-11
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: TERUMO sent an Urgent Medical Device Recall letter dated October 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo has determined that a field correction is required to notify affected customers that the boards may fail, instruct the users that in a case of failure to swich to the second channel on the device or use a back-up unit, and that TCVS will replace the affected boards. Customers with questions were instructed to call 1-800-621-2818. For questions regarding this recall call 734-741-6173.
Quantity in commerce: 15 units
Distribution: Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
Product codes and lots: Catalog number: 817168 and serial numbers: 824POOO023, 831 P001130, 831 P001133, 831 P001136, 831 P001140, 831 POO1141 , 831 P001144, 831 P001145, 831 P001146, 831 P001149, 831 P001151, 831 P001159, 831P001161, 831P001164, and 836POOOO05.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0279-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0278-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-13
Z-0279-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-13

Product code DWC

K071521Class IITerumo Hx2 Temperature Management SystemTerumo Cardiovascular Systems Corp. / cleared 2007-11-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)