v|tome|x L Series non-destructive testing cabinet x-ray systems — Class II medical device recall Z-0442-2021
Terminated recall by Ge Inspection Technologies Llc, reported 2020-11-25. It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning signals does not
| Recall number | Z-0442-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Ge Inspection Technologies Llc, Skaneateles Falls, NY, United States |
| Recall initiated | 2020-09-29 |
| Classified | 2020-11-13 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2023-05-02 |
| Countries outside the US | CA |
Product
v|tome|x L Series non-destructive testing cabinet x-ray systems
Reason for recall
It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning signals does not provide "Audible and visible warning signals within the cabinet" if the "warm up" mode was not completed after initializing the system when first turned on.
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-0442-2021. 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.