HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supply

FDA device recall Z-0278-2013 · posted 2012-11-13 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DWC

Quantity affected

19 units

Distribution

Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI

Date initiated

2012-10-16

Date posted

2012-11-13

Date terminated

2013-07-11

Location

Ann Arbor, MI

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