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RTVue XR Avanti
OPTOVUE, INC. · Model 100-2 · UDI-DI 00858848006391
1
510(k) clearances
15
Adverse events
11
Recalls
30
Facilities
Description
Ophthalmic Optical Coherence Tomography System w/230 VAC Table
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-14 | Carl Zeiss Meditec, Inc. | Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance. |
| 2021-11-03 | Haag-Streit USA Inc | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off |
| 2021-07-08 | Carl Zeiss Meditec, Inc. | Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device. |
| 2019-07-03 | Heidelberg Engineering GmbH | Error in the default configuration which could lead to the incorrect display of patient master data. |
| 2018-10-16 | Carl Zeiss Meditec, Inc. | Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/dow |
| 2017-12-08 | Heidelberg Engineering | FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 51 |
| 2012-09-07 | Optovue Inc. | Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and |
| 2012-02-21 | Optovue Inc. | A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version. |
| 2011-03-10 | Carl Zeiss Meditec Inc | A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient |
| 2011-03-10 | Carl Zeiss Meditec Inc | A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient |
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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.