Recall Z-0278-2013 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
HX2 Temp Manage SYS 120V 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.
| Date | Nov 13, 2012 (initiated Oct 16, 2012) |
| Status | Terminated |
| Reason | 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 | 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 | 19 units |
| Distribution | Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071521 | TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM Terumo Cardiovascular Systems Corp., Nov 21, 2007 |