FDA Medical Device Recalls (openFDA)
Comet Technologies Usa Inc: YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
- Recall number
- Z-2105-2019
- Recalling firm
- Comet Technologies Usa Inc
- Product
- YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
- Status
- Terminated
- Initiated
- 2018-10-01
- Posted
- not on file
- Terminated
- 2024-06-13
- Reason
- Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection of the power supply using only the movement of the door.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- The firm sent a notification letter dated July 2019, to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were informed that a service technician will be contacting you to schedule the retrofit service. For questions, call YXLON Service at (234) 284-7881.
- Quantity
- 77
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- X-Ray Systems
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RCE
- Firm FEI
- 3010948215
- Firm city
- Shelton
- Firm state
- CT
- 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