| | Class 2 Device Recall GaGa Pro Laser Light Show (LLS) projector systems |  |
| Date Initiated by Firm | September 23, 2022 |
| Date Posted | March 29, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1290-2023 |
| Recall Event ID |
91969 |
| |
| Product Classification |
High-power laser light show projector - Product Code REA
|
| Product | GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment. |
| Code Information |
GA-RGB3000, GA-A4-W10000, GA-ML500-8, GA-RGB8000, GA-RGB4000, GA-RGB5000,
GA-G4000M, and GA-ML1800 |
| FEI Number |
3013936259
|
Recalling Firm/ Manufacturer |
GAGA PRO LIGHTING EQUIPMENT CO., 1238 Longjiao Road Industrial Area Guangzhou China
|
| For Additional Information Contact | Christopher M Utter 443-953-1788 |
Manufacturer Reason for Recall | GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products. |
FDA Determined Cause 2 | 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 in Commerce | 11 units |
| Distribution | US Nationwide Distribution |
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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