Feb

2018

Metrotom 800 (130kV CT scanner) Industrial C Cl II

Company:Carl Zeiss Metrology Inc
Date of Enforcement Report 2/7/2018
Class lI:

PRODUCT

Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Recall Number Z-0379-2018

REASON
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..

RECALLING FIRM/MANUFACTURER
Carl Zeiss Metrology Inc., Maple Grove, MN on 11/14/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
13 US

DISTRIBUTION
Nationwide and Canada

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Metrotom 800 (130kV CT scanner) Industrial C Cl II

Amy Sellers

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