Espion

DIAGNOSYS LLC · Model D315 · UDI-DI 00850594007486

510(k) clearances

Adverse events

Recalls

Facilities

Description

E3 System; with 23" Monitor and ColorBurst and Mini OLED with table stand is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D315-1-1-NNNNN-23-2-T

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.