Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2092-2019Class II

ClubMax Laser Projection Series

Gk Photonics Inc / initiated 2019-07-10 / Open, Classified

Gk Photonics Inc began a recall of ClubMax Laser Projection Series on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2092-2019
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Gk Photonics Inc
Product
ClubMax Laser Projection Series
Product code
REA High-Power Laser Light Show Projector
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.
FDA root cause
Radiation Control for Health and Safety Act
Quantity in commerce
1291 total
Distribution
Unknown
Product codes and lots
ClubMax Laser Projection Series

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2092-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2092-2019Class IIOngoingFDA Mandated
Z-2093-2019Class IIOngoingFDA Mandated
Z-2094-2019Class IIOngoingFDA Mandated
Z-2095-2019Class IIOngoingFDA Mandated
Z-2096-2019Class IIOngoingFDA Mandated
Z-2097-2019Class IIOngoingFDA Mandated