Gk Photonics Spectrum Laser Projection Series Recalled for Safety Defect
Gk Photonics is recalling the Spectrum Laser Projection Series because the included remote interlock dongle may fail to prevent high-power laser radiation 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 (laser radiation exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Gk Photonics Inc is recalling the Spectrum Laser Projection Series due to a safety defect in the User Remote Interlock Dongle provided with the E-Stop Remote. The current dongle is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors.
This defect could unintentionally expose the user and/or observers to high power laser radiation. The recall is necessary to replace the dongle for safety reasons.
Consumers who possess this product should contact the recalling firm for instructions on how to obtain the replacement dongle.
The recalled product
- Product
- Spectrum 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)
- Spectrum 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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