Z-0870-2020Class II

EQ-400-RH-QZ and EQ-400-LH-BK products

Name: Z-0870-2020 EQ-400-RH-QZ and EQ-400-LH-BK products
Creator: Energetiq Technology Inc
Published: 2019-09-27
License: https://open.fda.gov/license/

Energetiq Technology Inc / initiated 2019-09-27 / Open, Classified / root cause: design

FDA source

Energetiq Technology Inc began a recall of 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... on 2019-09-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0870-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-27
Posted: 2020-01-29
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.
Product code: REK Research Laser
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.
Root cause tag: design
FDA 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 in commerce: 15
Distribution: Worldwide Distribution.
Product codes and lots: The defect concerns a total of fifteen (15) of our EQ-400 products. manufactured between June 3, 2016 and September 26, 2019.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0870-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0870-2020	Class II	Ongoing	FDA Mandated	2020-02-05	2020-01-29

Product code REK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)