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Class 2 Device Recall Terumo HX2 Temperature Management System |
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Date Initiated by Firm |
February 06, 2015 |
Date Posted |
February 13, 2015 |
Recall Status1 |
Terminated 3 on October 17, 2016 |
Recall Number |
Z-1116-2015 |
Recall Event ID |
70492 |
510(K)Number |
K071521
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Product Classification |
Controller, temperature, cardiopulmonary bypass - Product Code DWC
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Product |
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. |
Code Information |
HX2 Temperature Management System, 120V Catalog # 809810 serial numbers: 00016, 0001 1116 HX2 Temperature Management System, 100V Catalog # 812231 serial numbers: 0001, 1002, PT0003, PT0004 HX2 Temperature Management System, 240V Catalog # 812240 serial numbers: 0001, 0002 HX2 Temperature Management System, Trial Kit Catalog # 809810TK serial numbers: 1001 1042 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Rd Ann Arbor MI 48103-9586
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For Additional Information Contact |
Customer Call Center 800-521-2818
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Manufacturer 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.
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FDA Determined Cause 2 |
Device Design |
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. |
Quantity in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = DWC and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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