FDA Recall
Terminated
YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Recall: Z-2106-2019
·
Initiated October 1, 2018
Recall
- Recall Number
- Z-2106-2019
- Event Number
- 83295
- Firm
- Comet Technologies Usa Inc
- FEI Number
- 3010948215
- Product Code
- RCE
- Status
- Terminated
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- October 1, 2018
- Terminated
- June 13, 2024
- Address
- 100 Trap Falls Rd, Shelton, CT, 06484-4604
Description
YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
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.
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.
Distribution
US Nationwide Distribution
Quantity
93