CanadaThe Vivo 45 LS ventilator (model 230000; serial numbers S/N: 1R070KF to 1R100F9) is affected. In devices with the affected firmware versions, volume‑controlled ventilation modes (VCV, VCV‑SIMV and VCV‑MPV) can, under specific trigger conditions, deliver tidal volumes significantly below the set value; contact the manufacturer for additional information.
What's being recalled
Companies: Breas Medical AB, Foretagsvagen 1, Molnlycke, Sweden, 43533.
How to identify it
Affected products: Vivo 45 LS; Lot or serial number: S/N: 1R070KF to 1R100F9; Model or catalogue number: 230000
The hazard
In devices with the affected firmware versions, treatment in volume-controlled ventilation modes (VCV, VCV-SIMV and VCV-MPV) can, under specific trigger conditions, result in delivered tidal volume being reduced significantly below the set value.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)