Espion

DIAGNOSYS LLC · Model D310 · UDI-DI 00850594007028

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Profle System with Xenon ColorDome & ColorBurst 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). It's product configuration D310-R-1-CDXS-2-N.

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.