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Recall Observatory FDA recall evidence

Device product

YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control

Z-2106-2019

October 01, 2018

Class II

Product summary

Firm
Comet Technologies Usa Inc
Event
Event 83295
Status
Terminated
Classification
Class II
Quantity
93
Official record key
device-enforcement:Z-2106-2019

Official wording

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.

Code information: X-Ray Systems

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.