CLASS II ONGOING Device recall · Reported 5 Feb 2020 · FDA Enforcement Report

Eq-400-Rh-qz and Eq-400-Lh-bk products recalled by Energetiq Technology

Energetiq Technology is recalling Eq-400-Rh-qz and Eq-400-Lh-bk products. The recall was initiated on 27 Sep 2019 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled15

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0870-2020
FDA event ID: 84378
Recalling firm: Energetiq Technology, Woburn, MA
Classification: Class II
Status: Ongoing
Recall initiated: 27 Sep 2019
FDA classified: 29 Jan 2020
Reported: 5 Feb 2020
Type: FDA Mandated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

27 Sep 2019	Recall initiated by company
29 Jan 2020	Classified by FDA	+124 days
5 Feb 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution.

Questions about this recall

Is Eq-400-Rh-qz and Eq-400-Lh-bk products recalled?

Yes. Energetiq Technology recalled Eq-400-Rh-qz and Eq-400-Lh-bk products on 27 Sep 2019. The recall is Class II and its status is Ongoing. Recall number Z-0870-2020.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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