FDA Medical Device Recalls (openFDA)
ASTRA, LLC: 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 number
- Z-2100-2019
- 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
- Status
- Open, Classified
- Initiated
- 2019-04-25
- Posted
- not on file
- Terminated
- not on file
- Reason
- Failure to comply event due to incorrect labeling of a class 1 laser product.
- 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
- 1 product
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Model: L1, identified by Accession No. RH19A0069
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RFC
- Firm FEI
- 3015494597
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28