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Terminated

Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, temporal bones, and maxillofacial imaging.

FDA Recall Z-0561-2010 · Posted 2009-12-23

Recalling FirmXoran Technologies, Inc.
Recall StatusTerminated
Product CodeJAK
Date Initiated2008-09-17
Date Terminated2009-12-23
Product Quantity82

Reason for Recall

The system may overheat, causing poor image quality, interruption in image acquisition and/or damage to the system. Also, if the system is not allowed to cycle down prior to being restarted after an emergency stop, the x-ray and gantry motions will both resume.

Firm Action

A letter dated 9/17/08 was sent to each account telling them that the PLC would be upgraded. The firm visited each account and made corrections.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032243MINICAT DENTOCATXoran Technologies, Inc. · 2003-10-02

Official Source

View FDA Recall →

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

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