Recall Z-1290-2023 ยท REA High-Power Laser Light Show Projector
GAGA PRO LIGHTING EQUIPMENT CO.,
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
| Date | Mar 29, 2023 (initiated Sep 23, 2022) |
| Status | Open, Classified |
| Reason | GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GaGa. will send a Customer Notification letter to the affected customers by certified mail. The letter will identify the affected product, problem and actions to be taken. GAGA lighting will offer free upgrades to update your GAGA Laser projector to the current FDA requirements. Alternatively, you may choose to ship your laser projector to GAGA Lighting s U.S. agent, Laser Display Company, in order to get it fixed. GAGA Lighting will pay for shipping costs. GAGA Lighting, without charge, will bring the product into compliance with each applicable Federal standard for laser products. |
| Quantity | 11 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.