Recall Z-0870-2020 ยท REK Research Laser
Energetiq Technology Inc
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.
| Date | Sep 27, 2019 |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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 produ |
| Quantity | 15 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.