Z-2093-2019 Class II Ongoing
FDA device recall Z-2093-2019 was initiated by Gk Photonics Inc on July 10, 2019 and is designated Class II. 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 expo… The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- July 10, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- N/A
Product Description
Atom 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.
Distribution Pattern
Unknown
Code Information
Atom Laser Projection Series