Glendale, CA, United States
Gk Photonics Inc recalls
1 recall recorded since 2018, most recently on 10 July 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 July 2019
- Reason
- 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.
- Distribution
- Unknown
- Initiated
- FDA Mandated
- Recall numbers
- Z-2097-2019, Z-2096-2019, Z-2095-2019, Z-2093-2019, Z-2092-2019, Z-2094-2019
- Burstberry Laser Projection Series
- Logolas Laser Projection Series
- Maxim Laser Projection Series
- Atom Laser Projection Series
- ClubMax Laser Projection Series
- Spectrum Laser Projection Series
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.