Gk Photonics ClubMax Laser Projectors Recalled for Safety Interlock Defect
Gk Photonics is recalling ClubMax Laser Projection Series units because the remote interlock dongle may fail to prevent 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of high-power laser radiation exposure, which aligns with the 'Severe' criteria for significant injury risks.
Plain-English summary
Gk Photonics Inc is recalling 1,291 ClubMax Laser Projection Series units. The recall addresses a 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 users and/or observers to high-power laser radiation.
The affected units need to be replaced for safety reasons. The source text does not specify the distribution pattern or specific dates of sale.
The recalled product
- Product
- ClubMax Laser Projection Series
- Manufacturer
- Gk Photonics Inc
- Category
- Medical Device — Laser Projector
- Affected units
- 1,291
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)
- ClubMax 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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