FDAClass IINovember 6, 2013

Xoran MiniCAT CT Scanner recall

Xoran MiniCAT CT Scanner

Why was Xoran MiniCAT CT Scanner recalled?

A description of the defect in the product or the manner in which the product fails to comply wvith 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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Minicat

Product
Xoran MiniCAT CT Scanner
Recalling firm
Xoran Technologies, Inc.
Quantity
320
Distribution
Worldwide Distribution - Nationwide
Recall date
November 6, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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