Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly co
FDA device recall Z-1116-2015 · posted 2015-02-13 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DWC
- Quantity 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.
- Date initiated
- 2015-02-06
- Date posted
- 2015-02-13
- Date terminated
- 2016-10-17
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM (K071521) | Terumo Cardiovascular Systems Corp. | 2007-11-21 |