Z-0442-2021 Class II Terminated
FDA device recall Z-0442-2021 was initiated by Ge Inspection Technologies Llc on September 29, 2020 and is designated Class II. 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 w… The recall status is terminated (terminated May 2, 2023). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- September 29, 2020
- Termination Date
- May 2, 2023
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- N/A
Product Description
v|tome|x L Series non-destructive testing cabinet x-ray systems
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.
Distribution Pattern
USA Canada
Code Information
v/tome/x L Series (L240, L300 or L450)