Altrus Thermal Tissue Fusion Energy Sources recalled over fire hazard

Recall date

November 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ConMed Corporation recalls Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cut…

Recall number

Z-0359-2016

FDA classification

Class II

Brand / firm

ConMed Corporation

Sold / distributed

Distributed in the states of CA, and TX and in the country of Mexico.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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