Z-2316-2018 Class II Terminated
FDA device recall Z-2316-2018 was initiated by Wescam Inc on May 8, 2018 and is designated Class II. 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. The recall status is terminated (terminated August 24, 2021). Affected quantity: 29.
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2018
- Initiation Date
- May 8, 2018
- Termination Date
- August 24, 2021
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 29
Product Description
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 Pattern
US Nationwide Distribution
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