Xoran Technologies, Inc. Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, temporal bones, and maxillofacial imaging. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, temporal bones, and maxillofacial imaging.
Brand
Xoran Technologies, Inc.
Lot Codes / Batch Numbers
All units.
Products Sold
All units.
Xoran Technologies, Inc. is recalling Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone b due to The system may overheat, causing poor image quality, interruption in image acquisition and/or damage to the system. Also, if the system is not allowe. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026