Product Wiki · Recalls · Health Canada — Medical Devices

Reusable Non-Invasive Radio Frequency Electrode — recall 57291

Health Canada — Medical Devices · Canada · 2017-07-17 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 57291
Date of alert: 2017-07-17
Country / jurisdiction: Canada
Risk level: Type III
Risk type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: The RFE-10-D electrode was removed from the system licence on June 1, 2017. Thermi is in the process of obtaining a new device licence in Canada and intends to restart sale of the device to Canada once the renewal licence in approved. The recall is not related to device defectiveness. There have been no reported adverse events related to this device in Canada.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/reusable-non-invasive-radio-fr

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.

Reusable Non-Invasive Radio Frequency Electrode — recall 57291

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