Home › Device types › REM
Spectroscopy Instrument
FDA product code REM · Class N · Unknown
0
Registered devices
0
Adverse events
5
Recalls
0
510(k) clearances
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-04 | WASATCH PHOTONICS | Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes h |
| 2024-03-28 | Horiba Instruments Incorporated | HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular Instrument removed the primary light sourc |
| 2018-09-10 | GE Healthcare Biosciences | Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant. |
| 2018-05-08 | Zeiss, Carl Inc | In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit. |
| 2009-11-12 | Leica Microsystems, Inc. | A manufacturing defect was identified that could potentially result in the laser shutter not closing as intended which could result in the shutter not completel |
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