FDA Medical Device Recalls (openFDA)
Gk Photonics Inc: Spectrum Laser Projection Series
- Recall number
- Z-2094-2019
- Recalling firm
- Gk Photonics Inc
- Product
- Spectrum Laser Projection Series
- Status
- Open, Classified
- Initiated
- 2019-07-10
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- not on file
- Quantity
- not on file
- Distribution
- Unknown
- Lot, serial or model codes
- Spectrum Laser Projection Series
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BRX
- Firm FEI
- 3006314809
- Firm city
- Glendale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28