Ge Inspection Technologies Llc: Medical Device Recall in 2020 - (Recall #: Z-0442-2021)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2020.
Data Source: FDA.
Product Description:
v|tome|x L Series non-destructive testing cabinet x-ray systems
Product Classification:
Class II
Date Initiated: September 29, 2020
Date Posted: November 25, 2020
Recall Number: Z-0442-2021
Event ID: 86620
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.
Status: Terminated
Product Quantity: N/A
Code Information:
v/tome/x L Series (L240, L300 or L450)
Distribution Pattern:
USA Canada
Voluntary or Mandated:
FDA Mandated