FDA-Device2015-12-09Class II
Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
ConMed Corporation
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.
Sold states
Distributed in the states of CA, and TX and in the country of Mexico.
Affected count
9 devices
Manufactured in
525 French Rd, Utica, NY, United States
Products
Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0359-2016Don't want to check this manually?
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