FDA Recall
Terminated
v|tome|x L Series non-destructive testing cabinet x-ray systems
Recall: Z-0442-2021
·
Initiated September 29, 2020
Recall
- Recall Number
- Z-0442-2021
- Event Number
- 86620
- Firm
- Ge Inspection Technologies Llc
- FEI Number
- 3008369796
- Product Code
- RCE
- Status
- Terminated
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- September 29, 2020
- Terminated
- May 2, 2023
- Address
- 721 Visions Dr, Skaneateles Falls, NY, 13153-5314
Description
v|tome|x L Series non-destructive testing cabinet x-ray systems
Reason
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