Recall Z-2106-2019— Comet Technologies Usa Inc
Class II · Terminated
Class II FDA medical device recall by Comet Technologies Usa Inc, initiated 2018-10-01, terminated 2024-06-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Comet Technologies Usa Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-01
- Terminated
- 2024-06-13
- Firm location
- Shelton, CT, United States
Product description
YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.