Shelton, CT, United States
Comet Technologies Usa Inc recalls
1 recall recorded since 2018, most recently on 1 October 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 October 2018
- Terminated
- 13 June 2024
- 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.
- Distribution
- US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall numbers
- Z-2106-2019, Z-2105-2019
- YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
- YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.