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U.S. Department of Health and Human Services

Class 2 Device Recall Lidar System for Erosion Flume Application Model L1

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  Class 2 Device Recall Lidar System for Erosion Flume Application Model L1 see related information
Date Initiated by Firm April 25, 2019
Create Date August 07, 2019
Recall Status1 Open3, Classified
Recall Number Z-2100-2019
Recall Event ID 83302
Product Classification Laser Light Distance (or Detection) and Ranging (LIDAR) - Product Code RFC
Product Lidar System for Erosion Flume Application
Class 1 Laser Product

Product Usage:
Product is installed and fixed above a dynamic indoor flume designed for modeling water erosion in an indoor research environment with limited human access
Code Information Model: L1, identified by Accession No. RH19A0069
Recalling Firm/
Manufacturer		 ASTRA, LLC
282 Century Lane
Louisville CO 80027
Manufacturer Reason
for Recall		 Failure to comply event due to incorrect labeling of a class 1 laser product.
FDA Determined
Cause 2		 Error in labeling
Action Corrected labels have been applied to the installed product as of May 6, 2019. Additionally, all corresponding documentation provided to customer (users manual) has been updated to reflect the updated label. The correction implemented at no cost to the purchaser
Quantity in Commerce 1 product
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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