Z-0379-2018 Class II Ongoing
FDA device recall Z-0379-2018 was initiated by Carl Zeiss Metrology Inc on November 14, 2017 and is designated Class II. Reason for recall: 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 contro… The recall status is ongoing. Affected quantity: 13 US.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- November 14, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 13 US
Product Description
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Reason for Recall
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.
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.
Code Information
Serial Numbers: 152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342