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Recall Observatory FDA recall evidence

Device product

The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.

Z-2680-2014

August 27, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 69148
Status
Terminated
Classification
Class II
Quantity
62
Official record key
device-enforcement:Z-2680-2014

Official wording

Reason: 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.

Code information: Model numbers: 10281013, 10281163.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.