Medical device licence · 95553 · Class 4
FABIAN EVOLUTION VENTILATOR
Yes: licensed in Canada
Licence status Issued (active); first licensed August 10, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95553
- Licence holder
- Acutronic Medical Systems AgHirzel, Switzerland
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- August 10, 2015
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FABIAN +NCPAP EVOLUTION
- FABIAN THERAPY EVOLUTION
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 “fabian”. A notice may cover another product or only some lots: read it to see what it covers.
- Fabian VentilatorsJuly 10, 2024 · Anaesthesiology · Labelling and packaging · Type II
- Fabian™ HFO VentilatorMay 24, 2024 · Anaesthesiology · Performance · Type I
- Fabian HFOi VentilatorApril 12, 2022 · Anaesthesiology · Software defect · Type I
- Fabian HFO (2021-07-26)August 24, 2021 · Medical devices · Medical devices · Type I
- Fabian HFO (2021-07-26)August 17, 2021 · Medical devices · Medical devices · Type I
- fabian HFO, +nCPAP evolution, Therapy evolution (2021-04-22)May 26, 2021 · Medical devices · COVID - Medical devices · Type I
- Fabian HFO and Fabian +nCPAP Evolution Ventilators (2020-10-05)October 20, 2020 · Medical devices · Medical devices · Type I
- Fabian HFO and fabian Therapy evolution (2018-12-18)December 28, 2018 · Medical devices · Medical devices · Type I
- fabian Therapy evolution (2018-12-17)December 28, 2018 · Medical devices · Medical devices · Type I
- ACUTRONIC fabian HFO ventilator (2014-11-27)July 27, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.