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

Recall Z-0039-2014 — Xoran Minicat00158

U.S. FDA — Device Enforcement · United States · 2010-07-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0039-2014
Date of alert
2010-07-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Xoran Technologies, Inc.
Product category
device
Product type
Devices
Reported risk: The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health ha
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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