Micromed

MICROMED SPA · Model LED PHOTIC · UDI-DI 08033928121184

GWE Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

LED PHOTIC lamp is used in LED PHOTIC System for the stimulation of the patient during the EEG recording. The patient’s retina is stimulated with bright light flashes in order to stimulate brain activity changes. These changes can be used to evaluate brain functioning. The stimulation methods, like the photic stimulation, are integral part of the EEG exams.

Recalls

Date	Firm	Reason
2015-01-02	Natus Medical Incorporated	Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do
2007-04-02	Diopsys, Inc.	The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007.
2004-09-15	Diopsys Inc	The firm established no medical device quality system, no established quality plan and no established quality procedures.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.