ClearanceBrief
Recall Z-0442-2021 ยท RCE Cabinet X-Ray, Industrial

Ge Inspection Technologies Llc

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

DateSep 29, 2020
StatusTerminated
ReasonIt 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.
Root causeRadiation Control for Health and Safety Act
DistributionUSA Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.