Recall Z-2106-2019

Comet Technologies Usa Inc · initiated October 1, 2018

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

YXLON Cougar 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-2106-2019
Initiated
October 1, 2018
Terminated
June 13, 2024
Product code
RCE – Cabinet X-Ray, Industrial
Quantity
93
Distribution
US Nationwide Distribution
Recalling firm
Comet Technologies Usa Inc, Shelton, CT

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2105-2019 Class IIYXLON Cheetah 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