Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1498-2016 — 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 three-dimensional imaging and me

U.S. FDA — Device Enforcement · United States · 2016-03-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1498-2016
Date of alert: 2016-03-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Optovue, Inc.
Product category: device
Product type: Devices

Reported risk: A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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