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.

Company

Energetiq Technology Inc

Recall Initiated

September 27, 2019

Recall Number

Z-0870-2020

Quantity

15

Firm Location

Woburn, MA

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.

Lot / Code Info

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

Root Cause

Device Design

Action Taken

On October 28, 2019 Recall notification letters were sent to all customers of record that purchased the affected unit. The letter identified the affected product, problem and actions to be taken. Pending resolution of this issue we would advise all users if EQ-4001 units to follow the Operational Requirements that are attached to this letter. Specifically DO NOT REMOVE THE LASER COLLIMATOR FROM THE LAMP WHILE THE SYSTEM IS OPERATING. We have also enclosed a safety label and bolt caps with installation instructions. The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of H Health and Human Services, the details of which will be included in a subsequent communication to you.