HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System… — Class II medical device recall Z-0278-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-11-21, distributed nationwide. Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperat
| Recall number | Z-0278-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2012-10-16 |
| Classified | 2012-11-13 |
| Reported by FDA | 2012-11-21 |
| Terminated | 2013-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 19 units |
| Serial numbers | 1041, 1083, 1084, 1101-1116 |
| Model numbers | 809810 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0278-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.