FDA recall Z-0870-2020

Energetiq Technology Inc · Class II · 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.

Reason for recall

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.

Distribution

Worldwide Distribution.

Key facts

Status
Ongoing
Initiation date
2019-09-27
Report date
2020-02-05
Voluntary/Mandated
FDA Mandated
Location
Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0870-2020