FDA recall Z-2316-2018

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.

Reason for recall

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.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2018-05-08

Report date

2018-07-25

Termination date

2021-08-24

Voluntary/Mandated

FDA Mandated

Location

Burlington, Ontario, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2316-2018