Medical device recalls Moderate risk

Gk Photonics Inc recalls Burstberry Laser Projection Series

Recall date
July 10, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2097-2019
FDA classification
Class II
Brand / firm
Gk Photonics Inc
Sold / distributed
Unknown

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Burstberry Laser Projection Series

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