Z-1290-2023 Class II Ongoing
FDA device recall Z-1290-2023 was initiated by GAGA PRO LIGHTING EQUIPMENT CO., on September 23, 2022 and is designated Class II. Reason for recall: GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products. The recall status is ongoing. Affected quantity: 11 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2023
- Initiation Date
- September 23, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 11 units
Product Description
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
Reason for Recall
GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products.
Distribution Pattern
US Nationwide Distribution
Code Information
GA-RGB3000, GA-A4-W10000, GA-ML500-8, GA-RGB8000, GA-RGB4000, GA-RGB5000, GA-G4000M, and GA-ML1800