Medical Device Recall: HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Horiba Instruments Incorporated · March 28, 2024
Reason for Recall
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.
Distribution
US Nationwide and Worldwide Distribution
States Affected
NATIONWIDE
Quantity Affected
4 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2166-2024
Status: ongoing
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