Medical device recalls Moderate risk

Carl Zeiss Metrology Inc recalls Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic…

Recall date
November 14, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0379-2018
FDA classification
Class II
Brand / firm
Carl Zeiss Metrology Inc
Sold / distributed
Worldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.

Why it was recalled

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.

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

What was recalled

Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.

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