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Terminated

Xoran Minicat00202

FDA Recall Z-0038-2014 · Posted None

Recalling FirmXoran Technologies, Inc.
Recall StatusTerminated
Product CodeJAK
Date Initiated2010-07-27
Date Terminated2014-09-11
Product Quantity320

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

Firm Action

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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution - US nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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