Data Foundry

Medical device recalls 2018

Metrotom 800 — Class II medical device recall Z-0379-2018

Ongoing recall by Carl Zeiss Metrology Inc, reported 2018-02-07, distributed in AZ, CA, FL, GA, IL, NC, NJ, PR…. Due to a software error, it was observed that when the user closes the access door, the system will resume its

Recall numberZ-0379-2018
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedFDA mandated
Recalling firmCarl Zeiss Metrology Inc, Maple Grove, MN, United States
Recall initiated2017-11-14
Classified2018-01-26
Reported by FDA2018-02-07
DistributedAZ, CA, FL, GA, IL, NC, NJ, PR, WI
Countries outside the USCA
Quantity13 us
Reason classessoftware
Serial numbers152806, 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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0379-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.