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Terminated

Xoran Mini CT Scanner

FDA Recall Z-0036-2014 · Posted None

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

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

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.

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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