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Horiba Instruments Incorporated recalls HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

Recalled July 10, 2024 · FDA recall Z-2166-2024 · Horiba Instruments Incorporated

Hazard
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. · FDA Class II
Units
4 units
Sold at
US Nationwide and Worldwide Distribution

Description

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.

Product
HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Manufacturer(s)
Horiba Instruments Incorporated

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Horiba Instruments Incorporated recalls HORIBA custom configured fluorescence instrument, modular Fluorolog-QM | RecallWatchUSA