FDA Device recall Z-0279-2013
Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperatu…
- FDA Device
- Class II
- terminated
- Published 2012-11-21
On 2012-11-21 the FDA classified a Class II recall of Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperatu… 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-0279-2013 |
| 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
Tested AC Control BD, 120V, X2 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: 817168 and serial numbers: 824POOO023, 831 P001130, 831 P001133, 831 P001136, 831 P001140, 831 POO1141…Catalog number: 817168 and serial numbers: 824POOO023, 831 P001130, 831 P001133, 831 P001136, 831 P001140, 831 POO1141 , 831 P001144, 831 P001145, 831 P001146, 831 P001149, 831 P001151, 831 P001159, 831P001161, 831P001164, and 836POOOO05. |
|---|
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-0279-2013%22
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