Xoran Minicat00202
FDA Recall #Z-0038-2014 — Class II — July 27, 2010
Product Description
Xoran Minicat00202
Reason for Recall
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
Recalling Firm
Xoran Technologies, Inc. — Ann Arbor, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
320
Distribution
Worldwide Distribution - US nationwide
Code Information
minicat
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated