Thermi250

Starting date:

June 19, 2017

Posting date:

July 11, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-63888

• Reason
• Affected products

Reason

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.

Affected products