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U.S. Department of Health and Human Services

Class 2 Device Recall Combined Laser Illuminator/Rangefinder

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 Class 2 Device Recall Combined Laser Illuminator/Rangefindersee related information
Date Initiated by FirmMay 08, 2018
Create DateJuly 15, 2018
Recall Status1 Terminated 3 on August 24, 2021
Recall NumberZ-2316-2018
Recall Event ID 80392
Product Classification Surveying laser product - Product Code REP
ProductMX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.
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   
FEI Number 3000173214
Recalling Firm/
Manufacturer		 Wescam Inc
649 North Service Rd
Burlington Canada Ontario
For Additional Information Contact
905-633-4001
Manufacturer 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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionFirm sent a Service Bulletin dated June 2018 to customers. The Bulletin identified the affected product, problem and actions to be taken. For question call 888-5-WESCAM or email support.wescam@L3T.com.
Quantity in Commerce29
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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