Z-2100-2019Class II

Lidar System for Erosion Flume Application Class 1 Laser Product

Name: Z-2100-2019 Lidar System for Erosion Flume Application Class 1 Laser Product
Creator: Astra, Llc
Published: 2019-04-25
License: https://open.fda.gov/license/

Astra, LLC / initiated 2019-04-25 / Open, Classified / root cause: labeling and UDI

FDA source

ASTRA, LLC began a recall of Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume designed for... on 2019-04-25. FDA classified it as Class II and gives the reason as "Failure to comply event due to incorrect labeling of a class 1 laser product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2100-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-04-25
Posted: 2019-08-07
Recalling firm: Astra, LLC
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
Product code: RFC Laser Distance, Detection, Ranging (Lidar)
Reason for recall: Failure to comply event due to incorrect labeling of a class 1 laser product.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Model: L1, identified by Accession No. RH19A0069

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2100-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2100-2019	Class II	Ongoing	FDA Mandated	2019-08-14	2019-08-07

Product code RFC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)