FDA Recall
Open, Classified
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
Recall: Z-2100-2019
·
Initiated April 25, 2019
Recall
- Recall Number
- Z-2100-2019
- Event Number
- 83302
- Firm
- ASTRA, LLC
- FEI Number
- 3015494597
- Product Code
- RFC
- Status
- Open, Classified
- Root Cause
- Error in labeling
- Initiated
- April 25, 2019
- Address
- 282 Century Lane, Louisville, CO, 80027
Description
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
Reason
Failure to comply event due to incorrect labeling of a class 1 laser product.
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
Distribution
US Nationwide Distribution
Quantity
1 product