FDAClass IIFebruary 7, 2018

Metrotom 800 recall: Software Issue

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

Why was Metrotom 800 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: 152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342

Product
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Recalling firm
Carl Zeiss Metrology Inc
Quantity
13 US
Distribution
Worldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.
Recall date
February 7, 2018
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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