Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2097-2019 — Burstberry Laser Projection Series

U.S. FDA — Device Enforcement · United States · 2019-07-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2097-2019
Date of alert
2019-07-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Gk Photonics Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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