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Recall Observatory FDA recall evidence

Device product

North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware

Z-0063-2018

August 23, 2017

Class II

Product summary

Firm
North Star Imaging Inc
Event
Event 78254
Status
Ongoing
Classification
Class II
Quantity
US - 3 units
Official record key
device-enforcement:Z-0063-2018

Official wording

Reason: It was discovered a low-level radiation leak that was found on the NSI X-7000 system.

Code information: Model X-7000

Distribution pattern: US Distribution to the states of : PA, OH and KS.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It was discovered a low-level radiation leak that was found on the NSI X-7000 system.