Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1290-2023Class II

GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes...

Gaga Pro Lighting Equipment Co. / initiated 2022-09-23 / Open, Classified

GAGA PRO LIGHTING EQUIPMENT CO., began a recall of GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment on . FDA classified it as Class II and gives the reason as "GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1290-2023
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Gaga Pro Lighting Equipment Co.
Product
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
Product code
REA High-Power Laser Light Show Projector
Reason for recall
GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products.
FDA 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 in commerce
11 units
Distribution
US Nationwide Distribution
Product codes and lots
GA-RGB3000, GA-A4-W10000, GA-ML500-8, GA-RGB8000, GA-RGB4000, GA-RGB5000, GA-G4000M, and GA-ML1800

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1290-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1290-2023Class IIOngoingFDA Mandated