Gk Photonics Recalls
6 recalls on record · August 14, 2019 to August 14, 2019 · Medical Devices
August 14, 2019Medical DevicesFDA
Gk Photonics Inc recalls Burstberry Laser Projection Series
Hazard: The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
August 14, 2019Medical DevicesFDA
Gk Photonics Inc recalls Logolas Laser Projection Series
Hazard: The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
August 14, 2019Medical DevicesFDA
Gk Photonics Inc recalls Maxim Laser Projection Series
Hazard: The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
August 14, 2019Medical DevicesFDA
Gk Photonics Inc recalls Spectrum Laser Projection Series
Hazard: The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
August 14, 2019Medical DevicesFDA
Gk Photonics Inc recalls Atom Laser Projection Series
Hazard: The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
August 14, 2019Medical DevicesFDA
Gk Photonics Inc recalls ClubMax Laser Projection Series
Hazard: The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.