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

Recall Z-0024-2013 — Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont

U.S. FDA — Device Enforcement · United States · 2012-09-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0024-2013
Date of alert: 2012-09-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Optovue Inc.
Product category: device
Product type: Devices

Reported risk: 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 Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.

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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