FDA Recall
Open, Classified
Logolas Laser Projection Series
Recall: Z-2096-2019
·
Initiated July 10, 2019
Recall
- Recall Number
- Z-2096-2019
- Event Number
- 83438
- Firm
- Gk Photonics Inc
- FEI Number
- 3006314809
- Product Code
- REA
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- July 10, 2019
- Address
- 717 Ridge Dr, Glendale, CA, 91206-1752
Description
Logolas Laser Projection Series
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