Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0442-2021 — v|tome|x L Series non-destructive testing cabinet x-ray systems

U.S. FDA — Device Enforcement · United States · 2020-09-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0442-2021
Date of alert
2020-09-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ge Inspection Technologies Llc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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