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U.S. Department of Health and Human Services

Class 2 Device Recall HORIBA custom configured fluorescence instrument

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 Class 2 Device Recall HORIBA custom configured fluorescence instrumentsee related information
Date Initiated by FirmMarch 28, 2024
Date PostedJuly 01, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2166-2024
Recall Event ID 94839
Product Classification Spectroscopy instrument - Product Code REM
ProductHORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Code Information Modular Fluorolog-QM
FEI Number 3014443691
Recalling Firm/
Manufacturer		 Horiba Instruments Incorporated
20 Knightsbridge Rd
Piscataway NJ 08854-3913
For Additional Information ContactJeffrey Hendrickson
732-623-8146
Manufacturer 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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionHoriba 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 in Commerce4 units
DistributionUS Nationwide and Worldwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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