Xoran Technologies, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0039-2014)

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 Minicat00158

Product Classification:

Class II

Date Initiated: July 27, 2010

Date Posted: November 6, 2013

Recall Number: Z-0039-2014

Event ID: 66338

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

Status: Terminated

Product Quantity: N/A

Code Information:

minicat

Distribution Pattern:

Worldwide Distribution - US nationwide

Voluntary or Mandated:

Voluntary: Firm initiated