FDA Device Recall Z-0036-2014: Xoran Technologies, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0036-2014.

Recall Res Number

Z-0036-2014

Recalling Firm / Manufacturer

Xoran Technologies, Inc.

FEI Number

3004198450

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2010-07-27

Date Posted

N/A

Date Terminated

2014-09-11

Product Code

JAK

Event Number

66335

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

Action Details All of the MiniCAT CT Scanners subject to these complaints were serviced by Xoran technicians and the out-of-specifications devices were brought into specification. This was accomplished by either readjusting the settings or by installing a new component.

Distribution Pattern Worldwide Distribution - US nationwide

Code Information / Serial Numbers Minicat

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Medical Device Recall: Z-0036-2014

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer