Medical device recalls Moderate risk

ASTRA product recalled over labeling errors

Recall date
April 25, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
ASTRA, LLC recalls Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a…
Recall number
Z-2100-2019
FDA classification
Class II
Brand / firm
ASTRA, LLC
Sold / distributed
US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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