Camera, Ophthalmic, Ac-powered

The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System

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 allowable limits in earth leakage current, touch current in a single fault condition (of open ground) and patient leakage current in a single fault condition (of open ground).

Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye.

Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.

Halogen Lamp component in RetCam 3 System -

One 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 RetCam 3 computer module.

RetCam 3, RetCam Portable and RetCam Shuttle;

Software 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.

NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic image

Under certain circumstances, the Left eye image may be saved as the Right eye image.

Retcam3 & Retcam Shuttle with version 6.0 software.

Still images extracted from video recordings may be mislabeled as to right and left eye.

iFusion, Device Listing Number D203271.

FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

Merge Eye Station

This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.

Merge Eye Station.

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 reduce the risk to patient health.