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

Recall Z-2477-2015 — OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refrac

U.S. FDA — Device Enforcement · United States · 2015-06-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2477-2015
Date of alert: 2015-06-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Nidek Inc
Product category: device
Product type: Devices

Reported risk: Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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