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Recall Observatory FDA recall evidence

Device product

HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

Z-2166-2024

March 28, 2024

Class II

Product summary

Firm
Horiba Instruments Incorporated
Event
Event 94839
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-2166-2024

Official wording

Reason: HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular Instrument removed the primary light source and the excitation monochromator. A plastic cap was installed to plug the optical port, where a more durable beam stop should have been used. The defect may allow the class 4 laser beam to burn (or transmit) through the plastic cap to exit the protective enclosure.

Code information: Modular Fluorolog-QM

Distribution pattern: US Nationwide and Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular Instrument removed the primary light source and the excitation monochromator. A plastic cap was installed to plug the optical port, where a more durable beam stop should have been used. The defect may allow the class 4 laser beam to burn (or transmit) through the plastic cap to exit the protective enclosure.