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Recall Observatory FDA recall evidence

Device product

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

Z-0442-2021

September 29, 2020

Class II

Product summary

Firm
Ge Inspection Technologies Llc
Event
Event 86620
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0442-2021

Official wording

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.

Code information: v/tome/x L Series (L240, L300 or L450)

Distribution pattern: USA Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.