Optovue iVue OCT Systems Recalled for Software Display Anomaly
Optovue is recalling iVue and iVue 500 OCT systems due to a software anomaly that may display duplicate eye images instead of distinct right and left views.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a software display error that could lead to misinterpretation of medical images, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Optovue, Inc. is recalling 40 units of iVue and iVue 500 (now called iScan) Optical Coherence Tomography (OCT) systems. The recall affects specific software versions, 2016.0.0.127 for the United States and 2016.1.0.127 for foreign markets. These devices are non-contact, high-resolution tomographic imaging systems intended for in vivo imaging of anterior and posterior ocular structures, including the retina and optic disc.
The recall is due to a detected software anomaly involving the Normative Database. If a user scrolls on the map, the system may display images of the same eye rather than distinct images of the right and left eyes. This issue could lead to incorrect clinical interpretation of the imaging data.
The affected units were distributed to facilities in Pennsylvania, California, Illinois, Hawaii, Missouri, Colorado, Georgia, Maine, Indiana, Arizona, West Virginia, Virginia, Florida, Arkansas, Utah, Nebraska, Nevada, Louisiana, Tennessee, Kansas, and Oklahoma. Foreign distribution details are forthcoming. Users should contact Optovue for instructions on how to resolve the software issue.
The recalled product
- Product
- iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and…
- Manufacturer
- Optovue, Inc.
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 26507
- 26496
- 26558
- 22738
- 26139
- 26442
- 25720
- 25079
- 25142
- 23298
- 21990
- 23461
- 24199
- 25843
- 26572
- 26550
- 22971
- 26495
- 22652
- 25389
Distribution
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