Recall Z-2166-2024 ยท REM Spectroscopy Instrument
Horiba Instruments Incorporated
HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
| Date | Jul 1, 2024 (initiated Mar 28, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Horiba plans to issue an IMPORTANT ELECTRONIC PRODUCT RADIATION WARNING letter to notify affected customers. The notification will Identify the affected product involved, description of the defect, safety hazard imposed: and corrective actions, For questions, call (732) 623-8146. |
| Quantity | 4 units |
| Distribution | US Nationwide and Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.