Recall Z-2105-2019 ยท RCE Cabinet X-Ray, Industrial
Comet Technologies Usa Inc
YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
| Date | Oct 1, 2018 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.