FDA-Device2018-02-07Class II
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Carl Zeiss Metrology Inc
Hazard
Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user initiating x-ray generation from the control panel.
Sold states
Worldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.
Affected count
13 US
Manufactured in
6250 Sycamore Ln N, Maple Grove, MN, United States
Products
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0379-2018Don't want to check this manually?
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