FDA recall Z-0442-2021

Product

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

USA Canada

Key facts

Status

Terminated

Initiation date

2020-09-29

Report date

2020-11-25

Termination date

2023-05-02

Voluntary/Mandated

FDA Mandated

Location

Skaneateles Falls, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0442-2021