Recall Z-0442-2021— Ge Inspection Technologies Llc
Class II · Terminated
Class II FDA medical device recall by Ge Inspection Technologies Llc, initiated 2020-09-29, terminated 2023-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Ge Inspection Technologies Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-29
- Terminated
- 2023-05-02
- Firm location
- Skaneateles Falls, NY, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.