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FF450plus
Carl Zeiss Meditec AG · Model FF450plus · UDI-DI 04049471093032
1
510(k) clearances
150
Adverse events
9
Recalls
65
Facilities
Description
The FF 450plus is a monocular retina camera for routine use. It is designed to capture images of the eye, especially the retina area, as well as surrounding areas, to aid diagnosing or monitoring diseases of the eye that may be observed and photographed. If used in combination with dedicated optional equipment (electronic image sensors, digital archiving system) the system allows images to be displayed, stored, manipulated and archived digitally.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-12-20 | Merge 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 |
| 2017-07-27 | Optovue, Inc. | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| 2016-12-09 | Merge 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. |
| 2016-12-09 | Merge 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 |
| 2014-06-16 | Nidek Inc | Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. |
| 2014-03-07 | Clarity Medical Systems Inc | 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 |
| 2014-01-24 | Clarity Medical Systems Inc | 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. |
| 2013-08-01 | Nidek Inc | Under certain circumstances, the Left eye image may be saved as the Right eye image. |
| 2012-02-02 | Clarity Medical Systems Inc | Still images extracted from video recordings may be mislabeled as to right and left eye. |
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Get your free API keyRead the docsData 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.