Z-0442-2021Class II

v|tome|x L Series non-destructive testing cabinet x-ray systems

Name: Z-0442-2021 v|tome|x L Series non-destructive testing cabinet x-ray systems
Creator: Ge Inspection Technologies Llc
Published: 2020-09-29
License: https://open.fda.gov/license/

GE Inspection Technologies, LP / initiated 2020-09-29 / Terminated

FDA source

Ge Inspection Technologies Llc began a recall of v|tome|x L Series non-destructive testing cabinet x-ray systems on 2020-09-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0442-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-29
Posted: 2020-11-13
Terminated: 2023-05-02
Recalling firm: GE Inspection Technologies, LP
Product: v|tome|x L Series non-destructive testing cabinet x-ray systems
Product code: RCE Cabinet X-Ray, Industrial
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.
FDA root cause: Radiation Control for Health and Safety Act
Distribution: USA Canada
Product codes and lots: v/tome/x L Series (L240, L300 or L450)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0442-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0442-2021	Class II	Terminated	FDA Mandated	2020-11-25	2020-11-13

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)