Xoran Mini CT Scanner
FDA Recall #Z-0036-2014 — Class II — July 27, 2010
Product Description
Xoran Mini CT Scanner
Reason for Recall
A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; 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 evalu
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