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Recall Observatory FDA recall evidence

Device product

United Nuclear Scientific High Power Handheld Lasers. Laser products

Z-0051-2018

August 25, 2016

Class II

Product summary

Firm
United Nuclear Scientific Supplies, LLC
Event
Event 78389
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0051-2018

Official wording

Reason: Failure to comply with the laser class limitation listed in the performance standard for Specific Use Laser products.

Code information: Surveying Leveling and Alignment (SLA) laser products

Distribution pattern: US Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failure to comply with the laser class limitation listed in the performance standard for Specific Use Laser products.