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
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
- Device type
- Other Medical Devices
Timeline
| 10 Jul 2019 | Recall initiated by company | |
| 7 Aug 2019 | Classified by FDA | +28 days |
| 14 Aug 2019 | 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
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Spectrum Laser Projection Series recalled by Gk Photonics | Gk Photonics | Other | CA |
| Device | CLASS II | ClubMax Laser Projection Series recalled by Gk Photonics | Gk Photonics | Other | CA |
| Device | CLASS II | Atom Laser Projection Series recalled by Gk Photonics | Gk Photonics | Other | CA |
| Device | CLASS II | Maxim Laser Projection Series recalled by Gk Photonics | Gk Photonics | Other | CA |
| Device | CLASS II | Burstberry Laser Projection Series recalled by Gk Photonics | Gk Photonics | Other | CA |
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