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Thermi250 — recall 57049

Health Canada — Medical Devices · Canada · 2017-07-11 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 57049
Date of alert: 2017-07-11
Country / jurisdiction: Canada
Authority classification: Type III
Notice type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: Bios determined on May 17th, 2017 that in a limited number of Thermi250 Radiofrequency Systems, the "pause" button shown in the software operating view, is not working as intended when pressed based on investigation into a reported event. In these affected systems, when the user presses the "pause" button, the generator will continue to emit RF energy, and the user may not take the necessary safety precautions to avoid micro-discharges as described in the user's manual.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/thermi250

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Thermi250 — recall 57049

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