FDAClass IIOctober 1, 2014

The Ysio Systems with software version VC10 The Ysio recall

The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest…

Why was The Ysio Systems with software version VC10 The Ysio recalled?

Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated.

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?

Model numbers: 10281013, 10281163.

Product
The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
62
Distribution
Nationwide Distribution.
Recall date
October 1, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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