FDAFDA · Food and drugs·Recall number Z-0039-2014
Xoran Minicat00158
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
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 evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health ha
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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