FDA Device recall Z-0589-2016
Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to c…
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to c… by Maquet Cardiovascular Us Sales, citing failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the pow….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0589-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-13 |
| Published | 2016-01-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
Product
Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Reason
Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. This can shut down the compressor or the entire HCU 30 Type 2 unit.
Identifiers
| code_info | HCU 30 Base Unit 100 - 120 V, Model Number 704629/70103.4371 HCU 30 Base Unit 200 - 240 V, Model Number 704631/70103.4…HCU 30 Base Unit 100 - 120 V, Model Number 704629/70103.4371 HCU 30 Base Unit 200 - 240 V, Model Number 704631/70103.4642 HCU 30 Base Unit Canadian/US, Model Number 705501/70103.4653 Heater Cooler Unit 30 with Serial Number <93101480 The affected power supply boards have serial numbers less than 107006001. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0589-2016%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.