FDA Medical Device Recalls (openFDA)
Carl Zeiss Metrology Inc: 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
- 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.
- Status
- Open, Classified
- Initiated
- 2017-11-14
- Posted
- not on file
- Terminated
- not on file
- 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.
- 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
- 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.
- Lot, serial or model codes
- Serial Numbers: 152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RCE
- Firm FEI
- 3003902825
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28