Z-0379-2018Class II

Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made...

Name: Z-0379-2018 Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made...
Creator: Carl Zeiss Metrology Inc
Published: 2017-11-14
License: https://open.fda.gov/license/

Carl Zeiss Metrology Inc / initiated 2017-11-14 / Open, Classified / root cause: software

FDA source

Carl Zeiss Metrology Inc began a recall of Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal on 2017-11-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0379-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-11-14
Posted: 2018-01-26
Recalling firm: Carl Zeiss Metrology Inc
Product: Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Product code: RCE Cabinet X-Ray, Industrial
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.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Zeiss sent an Safety Notice Letter dated September 28, 2017, to the customers advising them of the recall. The affected device was identified as well as the issue involved. Customers are to complete and return the confirmation- waiver form. During the next scheduled service event, a ZEISS field service technician will update the Metrotom operating system. The corrections are to be made free of charge, and will be completed by March 2018. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (763) 203-4267.
Quantity in commerce: 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.
Product codes and lots: Serial Numbers: 152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0379-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0379-2018	Class II	Ongoing	FDA Mandated	2018-02-07	2018-01-26

Product code RCE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)