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

Recall Z-2202-2013 — Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.

U.S. FDA — Device Enforcement · United States · 2013-08-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2202-2013
Date of alert
2013-08-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Sonogage Inc
Product category
device
Product type
Devices
Reported risk: During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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