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FDAFDA · Food and drugs·Recall number Z-0379-2018

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

Published February 7, 2018 · Recall initiated: November 14, 2017

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

FDA Mandated · Letter

Recall details

Manufacturer
Carl Zeiss Metrology Inc
Distributor
Worldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.
Lot
Serial Numbers: 152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342
Risk classification
Class II
Area (FDA)
device
Country
United States

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