FDA recall Z-2106-2019

Product

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.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2018-10-01

Report date

2019-08-14

Termination date

2024-06-13

Voluntary/Mandated

FDA Mandated

Location

Shelton, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2106-2019