FDA Device recall Z-1116-2015
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperat…
- FDA Device
- Class II
- terminated
- Published 2015-02-25
On 2015-02-25 the FDA classified a Class II recall of Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperat… by Terumo Cardiovascular Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1116-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-06 |
| Published | 2015-02-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | HX2 Temperature Management System, 120V Catalog # 809810 serial numbers: 00016, 0001 1116 HX2 Temperature Mana…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 |
|---|
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-1116-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.