Burstberry Laser Projection Series — Class II medical device recall Z-2097-2019
Ongoing recall by Gk Photonics Inc, reported 2019-08-14. The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FD
| Recall number | Z-2097-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Gk Photonics Inc, Glendale, CA, United States |
| Recall initiated | 2019-07-10 |
| Classified | 2019-08-07 |
| Reported by FDA | 2019-08-14 |
Product
Burstberry 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2097-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.