Gk Photonics Atom Laser Projection Series Recalled for Safety Compliance
Gk Photonics Inc is recalling the Atom Laser Projection Series because the provided remote interlock dongle does not fully comply with FDA manual reset requirements, posing a risk of high-power laser exposure.
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: The recall involves a risk-of-harm product (high power laser radiation) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Gk Photonics Inc is recalling the Atom Laser Projection Series. The recall is due to a defect in the User Remote Interlock Dongle provided with the E-Stop Remote. This component is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors.
The defect could unintentionally expose the user and/or observers to high power laser radiation. The source text does not specify the number of units affected, the distribution scope, or any reported injuries or illnesses.
Consumers should replace the User Remote Interlock Dongle for safety reasons. The source text does not provide specific instructions on how to obtain the replacement or contact the manufacturer.
The recalled product
- Product
- Atom Laser Projection Series
- Manufacturer
- Gk Photonics Inc
- Category
- Medical Device — Laser Projector
- Hazard
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 (1)
- Atom Laser Projection Series
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Gk Photonics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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