Recall Z-2060-2010 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI. The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of the patients blood and cardioplegia solution during cardiovascular bypass surgery. The system consists of a water tank,
| Date | Jun 11, 2010 |
| Status | Terminated |
| Reason | The HX2 Temperature Management System mixing valve may fail resulting in an unusable water channel and then the machine would go into standby mode. |
| Root cause | Device Design |
| Action | The firm, TERUMO Cardiovascular Systems, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 11, 2010, to the consignees. The letter describes the product, reason for correction, what to do in the event of failure, potential hazard, correction, affected population and action to be taken by the customers. The customers are instructed to review the correction notice, assure that all users are aware of this notice, and complete, sign and fax the attached Customer Response Form to Terumo CVS Customer Service at 800-292-6551. The Terumo CVS Customer Service Dept. will contact you upon re |
| Quantity | 100 |
| Distribution | Nationwide Distribution: AR, CA, CO, CT, FL, HI, IA, IL, KS, LA, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA 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 |