Health Canada — Medical Devices · Canada · 2020-08-14 · Type II
🏛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 →
Reported risk: SICAT IMPLANT is a standalone software application, i.e. a radiological visualization software for diagnosis and dental implant planning. We found that implant planning data exported from SICAT IMPLANT are not correct for one specific export format. The error in the export format might cause dentists to manufacture (or have manufactured) surgical guides which are incorrect. Using those guides might cause drilling into the jaw to be either not deep enough or to deep. A dentist might have to stop a surgical procedure, or the drilling when to deep might cause damage to structures within the jaw.
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.