Product Wiki · Recalls · Health Canada — Medical Devices

fabian Therapy evolution (2018-12-17) — recall 58969

Health Canada — Medical Devices · Canada · 2018-12-28 · Type I

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
58969
Date of alert
2018-12-28
Country / jurisdiction
Canada
Authority classification
Type I
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: A manufacturing defect in the front membrane panel overlay could cause the panel buttons to be electrically shorted, thus appearing to the system that the button is being depressed. When this happens, the system will continue to power cycle with alarming. Under the worst circumstances, if the ventilator ceases to deliver positive pressure breaths the patients the patient might experience transient systemic arterial hypercapnia and oxygen desaturation secondary to hypoventilation.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/fabian-therapy-evolution-2018-

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.

Related

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.