Recall Z-2094-2019— Gk Photonics Inc
Class II · Ongoing
Class II FDA medical device recall by Gk Photonics Inc, initiated 2019-07-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Spectrum 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..
- Recalling firm
- Gk Photonics Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-07-10
- Firm location
- Glendale, CA, United States
Product description
Spectrum Laser Projection Series
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.