Severity
Moderate
FDA Devices recall · Reported August 14, 2019
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…
Gk Photonics Inc recalled Spectrum Laser Projection Series - a moderate-severity action.
Spectrum Laser Projection Series was recalled by Gk Photonics Inc in August 14, 2019. Reason: The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the F…. Check the official notice for the remedy. Verify recall #Z-2094-2019 with the FDA Devices before acting.
The recall
Gk Photonics Inc issued this moderate-severity FDA Devices recall-The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the F….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2094-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2094-2019) was formally reported on August 14, 2019, with the manufacturer initiating the action on July 10, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Gk Photonics Inc is listed as the recalling firm, operating out of Glendale, CA. Federal records list the affected scope as N/A.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Unknown. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
N/A
Related Recalls
6
0 from same agency
Spectrum Laser Projection Series
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2094-2019 |
| Date reported | August 14, 2019 |
| Date initiated | July 10, 2019 |
| Recalling firm | Gk Photonics Inc |
| Firm location | Glendale, CA |
| Affected scope | N/A |
| Distribution | Unknown |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 14, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.