Xoran Technologies, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0036-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Xoran Mini CT Scanner

Product Classification:

Class II

Date Initiated: July 27, 2010

Date Posted: November 6, 2013

Recall Number: Z-0036-2014

Event ID: 66335

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

Status: Terminated

Product Quantity: 320

Code Information:

Minicat

Distribution Pattern:

Worldwide Distribution - US nationwide

Voluntary or Mandated:

Voluntary: Firm initiated