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Fundus Photo

Fundus Photo · Model CFD-440 · UDI-DI 00860010658109

HKI Prescription
1
510(k) clearances
150
Adverse events
9
Recalls
65
Facilities

Description

Fundus Photo Digital Imaging System including hardware and/or software

Recalls

DateFirmReason
2018-12-20Merge Healthcare, Inc.Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allo
2017-07-27Optovue, Inc.FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
2016-12-09Merge Healthcare, Inc.This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
2016-12-09Merge Healthcare, Inc.Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to
2014-06-16Nidek IncImage taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
2014-03-07Clarity Medical Systems IncOne lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the
2014-01-24Clarity Medical Systems IncSoftware anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
2013-08-01Nidek IncUnder certain circumstances, the Left eye image may be saved as the Right eye image.
2012-02-02Clarity Medical Systems IncStill images extracted from video recordings may be mislabeled as to right and left eye.

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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.