FDA Device recall Z-0442-2021
v|tome|x L Series non-destructive testing cabinet x-ray systems
- FDA Device
- Class II
- terminated
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of v|tome|x L Series non-destructive testing cabinet x-ray systems by Ge Inspection Technologies, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0442-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-29 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Inspection Technologies |
| Distribution | n/a |
Product
v|tome|x L Series non-destructive testing cabinet x-ray systems
Reason
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.
Identifiers
| code_info | v/tome/x L Series (L240, L300 or L450) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0442-2021%22
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