Health Canada — Medical Devices · Canada · 2015-11-03 · Type III
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Archived by the issuing authority — kept for reference
Reported risk: An issue with the placement of a capacitor in the H3+ Digital Holter 48 hour recorders has resulted in reduced battery life, causing the recorder to record for less than the expected time. H3+ Digital Holter recorders with serial numbers between 115110248400 and 115410276012 fail to meet the claim of 24-48 hours recording time.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.