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FDANovember 5, 2015device

Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a "Check Seal" message with an audible alarm and to stop the heating cycle.

What to do

FDA enforcement status: Terminated

Brands named

conmed

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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