Recall Z-2105-2019
Comet Technologies Usa Inc · initiated October 1, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Codes / lots: X-Ray Systems
Reason for recall
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.
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
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.
Details
- Recall number
- Z-2105-2019
- Initiated
- October 1, 2018
- Terminated
- June 13, 2024
- Product code
- RCE – Cabinet X-Ray, Industrial
- Quantity
- 77
- Distribution
- US Nationwide Distribution
- Recalling firm
- Comet Technologies Usa Inc, Shelton, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2106-2019 Class II | YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for…Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a… | 10/01/2018Terminated |