GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstr
Summary
The FDA issued a Class II for GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS by GAGA PRO LIGHTING EQUIPMENT CO.,. Reason: GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products..
Details
Source
Device Recall
External ID
Z-1290-2023
Action Date
2023-04-05
Status
Ongoing
Category
device
Product Description
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
Lot/Code Info: GA-RGB3000, GA-A4-W10000, GA-ML500-8, GA-RGB8000, GA-RGB4000, GA-RGB5000, GA-G4000M, and GA-ML1800
Quantity Affected: 11 units
Reason for Recall
GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products.
Distribution
US Nationwide Distribution
Type: FDA Mandated
Recall Initiated: 2022-09-23
Company
Guangzhou, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GAGA PRO LIGHTING EQUIPMENT CO.,) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GAGA PRO LIGHTING EQUIPMENT CO., have FDA actions?
This is the only FDA action we have on record for GAGA PRO LIGHTING EQUIPMENT CO., in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1290-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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