Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
FDA Recall Z-1116-2015 · Posted 2015-02-13
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDWC
Date Initiated2015-02-06
Date Terminated2016-10-17
Product Quantity103 units
Reason for Recall
Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals.
Firm Action
On 2/6/2015, URGENT MEDICAL DEVICE RECALL notifications were mailed to the affected hospitals. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call customer service at 1-800-521-2818.
Root Cause
Device Design
Distribution Pattern
US (nationwide) including the states of AR, CA, CO, CT, FL, IA, IL, KS, KY, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA, and WI and the country of Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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