Gk Photonics Maxim Laser Projection Series Recalled for Safety Defect
Gk Photonics is recalling the Maxim Laser Projection Series because the provided remote interlock dongle may not fully comply with FDA safety requirements, potentially exposing users to high-power laser radiation.
What this means for you
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 'High' severity criteria.
Plain-English summary
Gk Photonics Inc is recalling the Maxim 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.
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
- Maxim 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)
- Maxim 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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