Medical device licence · 28031 · Class 2
HEATER-COOLER UNIT 30 SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed March 23, 2001; ended December 6, 2024. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 28031
- Licence holder
- Maquet Cardiopulmonary GmbhRastatt, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 23, 2001
- Ended
- December 6, 2024
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HEATER-COOLER UNIT 30 SYSTEM - BLANKET CONNECTION KIT
- HEATER-COOLER UNIT 30 SYSTEM - COOLING BLANKET
- HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT, VARIOUS VOLTAGES
- HEATER-COOLER UNIT 30 SYSTEM - REMOTE CONTROL CABLE
- HEATER-COOLER UNIT 30 SYSTEM - REMOTE CONTROL UNIT
- HEATER-COOLER UNIT 30 SYSTEM - WATER SUPPLY TUBING
- JOSTRA HEATER-COOLER UNIT 30 SYSTEM - BLANKET CONNECTION KIT
- JOSTRA HEATER-COOLER UNIT 30 SYSTEM - COOLING BLANKET
- JOSTRA HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT, VARIOUS VOLTAGES
- JOSTRA HEATER-COOLER UNIT 30 SYSTEM - REMOTE CONTROL CABLE
- JOSTRA HEATER-COOLER UNIT 30 SYSTEM - REMOTE CONTROL UNIT
- JOSTRA HEATER-COOLER UNIT 30 SYSTEM - WATER SUPPLY TUBING
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “heater-cooler”. A notice may cover another product or only some lots: read it to see what it covers.
- Heater-Cooler Unit HCU 40February 6, 2025 · General hospital and personal use · Performance · Type II
- Heater-Cooler Unit HCU 40March 17, 2023 · General hospital and personal use · Performance · Type II
- HEATER-COOLER UNIT HCU40 (2021-08-25)September 10, 2021 · Medical devices · Medical devices · Type II
- Heater-Cooler Unit HCU 40 (2020-10-08)October 23, 2020 · Medical devices · Medical devices · Type II
- Heater-Cooler Unit HCU 40 (2020-08-17)September 4, 2020 · Medical devices · Medical devices · Type II
- Heater-Cooler Unit 30 System (2020-02-05)February 21, 2020 · Medical devices · Medical devices · Type II
- 3T Heater-Cooler Devices (2019-03-10)June 21, 2019 · Medical devices · Medical devices · Type II
- Heater-Cooler Unit HCU 40 (2018-11-26)January 9, 2019 · Medical devices · Medical devices · Type II
- Heater-Cooler Unit HCU 40 (2018-08-03)August 17, 2018 · Medical devices · Medical devices · Type II
- Stockert Heater-Cooler System 3TAugust 14, 2017 · Medical devices · Type II
- LivaNova Stöckert 3T Heater-Cooler Device - Risk of Mycobacterium chimaera InfectionsFebruary 17, 2017 · Medical devices · Product safety
- Heater-Cooler Unit HCU 40January 12, 2017 · Medical devices · Type III
- Sorin 3T Heater-Cooler SystemNovember 15, 2016 · Medical devices · Type II
- Heater-Cooler Devices - Risk of Nontuberculous Mycobacteria InfectionsOctober 21, 2016 · Medical devices · Product safety
- Heater-Cooler UnitsSeptember 9, 2016 · Medical devices · Type II
- HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT (2015-10-28)October 28, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.