FDAFDA · Food and drugs·Recall number Z-0036-2014
Xoran Mini CT Scanner
Published November 6, 2013 · Recall initiated: July 27, 2010
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Xoran Technologies, Inc.
- Distributor
- Worldwide Distribution - US nationwide
- Lot
- Minicat
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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