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Recall Observatory FDA recall evidence

Device product

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

Z-0379-2018

November 14, 2017

Class II

Product summary

Firm
Carl Zeiss Metrology Inc
Event
Event 78885
Status
Ongoing
Classification
Class II
Quantity
13 US
Official record key
device-enforcement:Z-0379-2018

Official wording

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.

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

Distribution pattern: Worldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software error