Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Combined Laser Illuminator/Rangefinder

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Combined Laser Illuminator/Rangefinder see related information
Date Initiated by Firm May 08, 2018
Create Date July 15, 2018
Recall Status1 Terminated 3 on August 24, 2021
Recall Number Z-2316-2018
Recall Event ID 80392
Product Classification Surveying laser product - Product Code REP
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.

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   
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
Action Firm 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 Commerce 29
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC 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.
-
-