Recall Z-2100-2019— ASTRA, LLC
Class II · Ongoing
Class II FDA medical device recall by ASTRA, LLC, initiated 2019-04-25. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Failure to comply event due to incorrect labeling of a class 1 laser product..
- Recalling firm
- ASTRA, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-04-25
- Firm location
- Louisville, CO, United States
Product 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 for recall
Failure to comply event due to incorrect labeling of a class 1 laser product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.