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Recall Observatory FDA recall evidence

Device product

MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.

Z-2316-2018

May 08, 2018

Class II

Product summary

Firm
Wescam Inc
Event
Event 80392
Status
Terminated
Classification
Class II
Quantity
29
Official record key
device-enforcement:Z-2316-2018

Official wording

Reason: Product has a nominal ocular hazard distance (NOHD) that is longer than specified and persons could be exposed to light in excess of the exposure limit.

Code information: L3 Wescam MX-10, part numbers 44620-203, 44620-211, 44620-213, 44620-215, 44620-221,4620-258, 44620-263, 44620-277, 45840-13, 45840-20, and 45840-23

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product has a nominal ocular hazard distance (NOHD) that is longer than specified and persons could be exposed to light in excess of the exposure limit.