Home / Recalls / Xoran Technologies, Inc. / Z-0036-2014

Z-0036-2014 Class II Terminated

Recalled by Xoran Technologies, Inc. — Ann Arbor, MI

Recall Details

Product Type
Devices
Report Date
November 6, 2013
Initiation Date
July 27, 2010
Termination Date
September 11, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
320

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

Distribution Pattern

Worldwide Distribution - US nationwide

Code Information

Minicat

Other recalls by Xoran Technologies, Inc.

  • Z-1210-2015 Class II — Xoran MiniCAT X-ray imaging device (September 8, 2014)
  • Z-0037-2014 Class II — Xoran MiniCAT CT Scanner (July 27, 2010)
  • Z-0038-2014 Class II — Xoran Minicat00202 (July 27, 2010)
  • Z-0040-2014 Class II — Xoran MiniCAT00202 (July 27, 2010)
  • Z-0039-2014 Class II — Xoran Minicat00158 (July 27, 2010)
  • Z-0041-2014 Class II — Xoran MiniCAT CT Scanner ID ENT00001 (December 14, 2009)