Recall Z-0870-2020— Energetiq Technology Inc
Class II · Ongoing
Class II FDA medical device recall by Energetiq Technology Inc, initiated 2019-09-27. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Energetiq Technology Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-09-27
- Firm location
- Woburn, MA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.