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Terminated

Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging.

FDA Recall Z-0296-2008 · Posted 2007-11-27

Recalling FirmXoran Technologies, Inc.
Recall StatusTerminated
Product CodeJAK
Date Initiated2006-07-13
Date Terminated2008-03-13
Product Quantity5

Reason for Recall

The hard drive may crash, resulting in loss of data from patient CT scans.

Firm Action

Consignee accounts were visited between 7/25/06 and 8/10/07 and the hard drives on their systems were replaced.

Root Cause

Finished device change control

Distribution Pattern

Nationwide Distribution: California, South Dakota, Tennessee, Utah and West Virginia.

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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