FDA Medical Device Recalls (openFDA)
Horiba Instruments Incorporated: HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
- Recall number
- Z-2166-2024
- Recalling firm
- Horiba Instruments Incorporated
- Product
- HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
- Status
- Open, Classified
- Initiated
- 2024-03-28
- Posted
- 2024-07-01
- Terminated
- not on file
- 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
- Lot, serial or model codes
- Modular Fluorolog-QM
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REM
- Firm FEI
- 3014443691
- Firm city
- Piscataway
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28