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

Recall Z-3036-2017 — Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications

U.S. FDA — Device Enforcement · United States · 2017-05-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3036-2017
Date of alert
2017-05-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
NeuroLogica Corporation
Product category
device
Product type
Devices
Reported risk: When performing the Stitching function on GU60A system, unintended area is exposed to radiation
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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