FDA Device Recall Z-0038-2014: Xoran Technologies, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0038-2014.

Recall Res Number

Z-0038-2014

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

66338

Product Quantity

320

Product Description Xoran Minicat00202

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

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. Xoran's Research & Development group is evaluating the current specification to see if the field specifications are appropriate and to ensure that proper testing protocols are communicated and are in place for use by 3 rd party testing organizations. In addition, Xoran has initiated CAPA # 18 0 that is looking at the source block with regard to evaluating the stability of the dose rating.

Distribution Pattern Worldwide Distribution - US nationwide

Code Information / Serial Numbers minicat

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Medical Device Recall: Z-0038-2014

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer