FDA Medical Device Recalls (openFDA)
Ge Inspection Technologies Llc: v|tome|x L Series non-destructive testing cabinet x-ray systems
- Recall number
- Z-0442-2021
- Recalling firm
- Ge Inspection Technologies Llc
- Product
- v|tome|x L Series non-destructive testing cabinet x-ray systems
- Status
- Terminated
- Initiated
- 2020-09-29
- Posted
- not on file
- Terminated
- 2023-05-02
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- not on file
- Quantity
- not on file
- Distribution
- USA Canada
- Lot, serial or model codes
- v/tome/x L Series (L240, L300 or L450)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RCE
- Firm FEI
- 3008369796
- Firm city
- Skaneateles Falls
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28