SEMA 3 Recall Due to ECG Processing Issue

Source: Health Canada · Canada

Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.

Health Canada recalls SEMA 3 software after identifying a potential discrepancy in ECG data processing when used with DEFIGARD Touch 7 or ARGUS PRO LifeCare 3 devices.

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

This notice was issued by Health Canada on August 5, 2026 and geographically references Canada. Its severity classification of "medium" 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, MedicalDevice.

What Happened

Health Canada has issued a recall for SEMA 3 software due to a potential discrepancy between the acquiring device and SEMA when an ECG is acquired with DEFIGARD Touch 7 or ARGUS PRO LifeCare 3 using the newest software. The issue stems from inadequate processing by SEMA of an already filtered signal.

Which Products Are Affected

  • SEMA 3 (model 6020.009411)
  • SEMA 3 (model 6020.012099)
  • SEMA 3 (model 6020.009412)

Lot or serial numbers: Not applicable. The affected company is Schiller Ag, Altgasse 68, Baar, Zug, Switzerland, 6341.

What You Should Do

SEMA should be updated to version 25.10. Consumers should contact the manufacturer for further instructions on the update.

Why This Matters

The software issue may result in inaccurate ECG signal processing, potentially affecting the reliability of cardiac data used in medical evaluations.

Source

Health Canada

Original source: Health Canada Official Notice ↗

All Product & Food Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Health Canada recalls SEMA 3 software after identifying a potential discrepancy in ECG data processing when used with DEFIGARD Touch 7 or ARGUS PRO LifeCare 3 devices.
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 "medium" severity. Stay informed and follow agency guidance.
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.