Z-0041-2014 Class II Terminated
FDA device recall Z-0041-2014 was initiated by Xoran Technologies, Inc. on December 14, 2009 and is designated Class II. Reason for recall: Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate. The recall status is terminated (terminated September 11, 2014). Affected quantity: 320.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2013
- Initiation Date
- December 14, 2009
- Termination Date
- September 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 320
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.
Distribution Pattern
Worldwide Distribution - US nationwide
Code Information
minicat