Health Canada Recalls Vivo 45 LS Medical Device

Source: Health Canada · Canada

Health Canada has recalled the Vivo 45 LS due to a potential issue in volume-controlled ventilation modes that could deliver reduced tidal volume.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on May 6, 2026 and geographically references Canada. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Product & Food Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly Health Canada detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized Health Canada recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, medical-device) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Health Canada has issued a recall for the Vivo 45 LS device because, in devices with affected firmware versions, treatment in volume-controlled ventilation modes (VCV, VCV-SIMV, and VCV-MPV) can result in the delivered tidal volume being significantly reduced below the set value.

Which Products Are Affected

The affected products include the Vivo 45 LS with serial numbers from 1R070KF to 1R100F9 and model or catalogue number 230000. No specific quantities, UPCs, or regions are detailed in the recall notice.

What You Should Do

For information on actions to take, refer to the Health Canada recall notice, as specific steps are not detailed in the provided data.

Why This Matters

This recall is significant because the issue could affect the proper functioning of medical ventilation devices, potentially posing serious health risks to users who rely on accurate tidal volume delivery.

Source

This information is from Health Canada. For full details, visit: https://recalls-rappels.canada.ca/en/alert-recall/vivo-45-ls

Original source: Health Canada Official Notice ↗

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Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Health Canada has recalled the Vivo 45 LS due to a potential issue in volume-controlled ventilation modes that could deliver reduced tidal volume.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.