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.
Reported: February 25, 2015 Initiated: February 6, 2015 #Z-1116-2015
Product Description
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.
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.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 103 units
- Distribution
- 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.
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 103 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 25, 2015. Severity: Moderate. Recall number: Z-1116-2015.
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