FDA Device recall Z-0278-2013
HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature con…
- FDA Device
- Class II
- terminated
- Published 2012-11-21
On 2012-11-21 the FDA classified a Class II recall of HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature con… by Terumo Cardiovascular Systems, citing based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0278-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-16 |
| Published | 2012-11-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Reason
Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up
Identifiers
| code_info | Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0278-2013%22
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