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Recall Observatory FDA recall evidence

Device 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

Z-2100-2019

April 25, 2019

Class II

Product summary

Firm
ASTRA, LLC
Event
Event 83302
Status
Ongoing
Classification
Class II
Quantity
1 product
Official record key
device-enforcement:Z-2100-2019

Official wording

Reason: Failure to comply event due to incorrect labeling of a class 1 laser product.

Code information: Model: L1, identified by Accession No. RH19A0069

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrect labeling