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Recall Observatory FDA recall evidence

Device product

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.

Z-0870-2020

September 27, 2019

Class II

Product summary

Firm
Energetiq Technology Inc
Event
Event 84378
Status
Ongoing
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-0870-2020

Official wording

Reason: 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.

Code information: The defect concerns a total of fifteen (15) of our EQ-400 products. manufactured between June 3, 2016 and September 26, 2019.

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.