The Recall Desk
HighFDA (Devices)·Z-2094-2019·Announced 2019-08-14

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.

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 (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

Same manufacturer · Gk Photonics Inc

See all →

Same hazard · laser radiation

See all →