Medical device recalls Moderate risk

Ge Inspection Technologies Llc recalls v|tome|x L Series non-destructive testing cabinet x-ray systems

Recall date
September 29, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0442-2021
FDA classification
Class II
Brand / firm
Ge Inspection Technologies Llc
Sold / distributed
USA Canada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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