GaGa Pro Class IV Laser Projectors Recalled for FDA Compliance Failure
GaGa Pro Lighting Equipment Co. manufactures Class IV Laser Light Show projectors that are being recalled due to non-compliance with FDA's Performance Standard for laser products. Eleven units distributed nationwide are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall for Class IV laser equipment that fails to comply with the FDA's Performance Standard for laser products. Class IV lasers present inherent risk of eye and burn injuries, and while no reported illnesses or injuries are documented, the non-compliance with mandatory safety performance standards qualifies this as a risk-of-harm product recall.
Plain-English summary
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS) projectors for demonstration and entertainment purposes. Eleven units of these projectors are subject to recall.
The manufacturers are recalling the projectors because they do not comply with the FDA's Performance Standard for laser products. Class IV laser devices require strict adherence to safety performance standards.
The affected models include GA-RGB3000, GA-A4-W10000, GA-ML500-8, GA-RGB8000, GA-RGB4000, GA-RGB5000, GA-G4000M, and GA-ML1800. These units were distributed nationwide.
The recalled product
- Product
- GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
- Manufacturer
- GAGA PRO LIGHTING EQUIPMENT CO.,
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- GA-RGB3000
- GA-A4-W10000
- GA-ML500-8
- GA-RGB8000
- GA-RGB4000
- GA-RGB5000
- GA-G4000M
- and GA-ML1800
Distribution
Distributed nationwide across the United States.
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