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ConMed Corporation recalls Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutt
Recalled December 9, 2015 · FDA recall Z-0359-2016 · ConMed
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. · FDA Class II
Units
9 devices
Sold at
Distributed in the states of CA, and TX and in the country of Mexico.
Description
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.
Product
Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
Manufacturer(s)
ConMed Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →