Health Canada — Medical Devices · Canada · 2020-03-13 · 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 →
Reported risk: Siemens is notifying users of MOBILETT Elara Max about a mechanical solution to prevent the side cover from getting loose. Siemens will perform a modification to the fixation of the system side cover to prevent the upper end of the cover from getting loose and creating a small gap. Due to the design the side cover cannot fall off, however, there may be a dislocation of the cover of a few millimeters to the system housing at the upper edge.
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.