FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0870-2020
- Recalling firm
- Energetiq Technology Inc
- 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.
- Status
- Open, Classified
- Initiated
- 2019-09-27
- Posted
- not on file
- Terminated
- not on file
- 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 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.
- Quantity
- 15
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- The defect concerns a total of fifteen (15) of our EQ-400 products. manufactured between June 3, 2016 and September 26, 2019.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REK
- Firm FEI
- 3005152898
- Firm city
- Woburn
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28