Medical device recalls Moderate risk

Energetiq Technology Inc recalls EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent n…

Recall date
September 27, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0870-2020
FDA classification
Class II
Brand / firm
Energetiq Technology Inc
Sold / distributed
Worldwide Distribution.

Why it was recalled

On September 27, 2019 Energetiq Technology (the manufacturer) discovered a problem with their EQ-400-RH-QZ and EQ-400-LH-BK products during routine manufacturing functional testing. It was noted that a safety interlock within the lamp does not function in a reliable manner to shut down the system if the laser collimator is removed from the lamp while the system is operating. This is a potential safety hazard for anyone working on or nearby the lamp.

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

What was recalled

EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.

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