CLASS II ONGOING Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

Logolas Laser Projection Series recalled by Gk Photonics

Gk Photonics is recalling Logolas Laser Projection Series. The recall was initiated on 10 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLogolas Laser Projection Series
Quantity recalledN/A

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-2096-2019
FDA event ID
83438
Recalling firm
Gk Photonics, Glendale, CA
Classification
Class II
Status
Ongoing
Recall initiated
10 Jul 2019
FDA classified
7 Aug 2019
Reported
14 Aug 2019
Type
FDA Mandated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

10 Jul 2019Recall initiated by company
7 Aug 2019Classified by FDA+28 days
14 Aug 2019Published 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

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

Product as listed by the FDA

Logolas Laser Projection Series

Where it was distributed

Unknown

Questions about this recall

Is Logolas Laser Projection Series recalled?

Yes. Gk Photonics recalled Logolas Laser Projection Series on 10 Jul 2019. The recall is Class II and its status is Ongoing. Recall number Z-2096-2019.

Why was it recalled?

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

Which lots are affected?

Logolas Laser Projection Series

Where was it sold?

Unknown

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.

More recalls from Gk Photonics

All 6

Other Other Medical Devices recalls

All 13,778