Recall Z-0041-2014— Xoran Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by Xoran Technologies, Inc., initiated 2009-12-14, terminated 2014-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Xoran MiniCAT CT Scanner ID ENT00001. Reason: Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate..
- Recalling firm
- Xoran Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2009-12-14
- Terminated
- 2014-09-11
- Firm location
- Ann Arbor, MI, United States
Product description
Xoran MiniCAT CT Scanner ID ENT00001
Reason for recall
Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.