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Official recall record

Cardiohelp-I (ref 75365)

Health Canada — Medical Devices · 2024-04-08 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-04-08
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

During service measurements on the Cardiohelp-I devices in the field, it was noticed that the measured patient leakage current exceeded the limit values of 50 μa specified in standard EN 60601-1:2006 + a1:2013. Patient leakage currents of up to 1337 μa were measured. Investigations have shown that only Cardiohelp-I devices with installed sensor panels (701051308) with an old sensor bridge (701049193) hardware version are affected. The new hardware version is not affected. Recall Start Date: March 18, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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