FDA (Devices) recall action 83438
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Gk Photonics is recalling the Spectrum Laser Projection Series because the included remote interlock dongle may fail to prevent high-power laser radiation exposure.
Gk Photonics Inc is recalling the Burstberry Laser Projection Series because the provided remote interlock dongle fails to meet FDA safety requirements, posing a risk of high-power laser radiation exposure.
Gk Photonics Inc is recalling the Atom Laser Projection Series because the provided remote interlock dongle does not fully comply with FDA manual reset requirements, posing a risk of high-power laser exposure.
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.
Gk Photonics is recalling ClubMax Laser Projection Series units because the remote interlock dongle may fail to prevent high-power laser exposure.
Gk Photonics is recalling Logolas Laser Projection Series units because the remote interlock dongle may not fully comply with FDA safety requirements, posing a risk of high-power laser exposure.