Gk Photonics Inc: Medical Device Recall in 2019 - (Recall #: Z-2095-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Maxim Laser Projection Series

Product Classification:

Class II

Date Initiated: July 10, 2019

Date Posted: August 14, 2019

Recall Number: Z-2095-2019

Event ID: 83438

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.

Status: Ongoing

Product Quantity: N/A

Code Information:

Maxim Laser Projection Series

Distribution Pattern:

Unknown

Voluntary or Mandated:

FDA Mandated