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.
FDA Recall Z-2680-2014 · Posted 2014-09-23
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeKPR
Date Initiated2014-08-27
Date Terminated2015-03-30
Product Quantity62
Reason for Recall
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.
Firm Action
The firm, Siemens, sent a "Safety Advisory Notice" dated August 27, 2014, to end users/customers. The notice identified the product, problem, and action to be taken. The customers were instructed to follow the instructions in the notice; promptly notify and instruct all the staff at your organization who have to be aware of this problem; forward this safety information to other organizations affected by this measure; and if the device has been sold and therefore no longer in your possession, forward to new owner.
Siemens prepared a field modification of the Ysio systems with a hardware upgrade. This field modification will be available in September 2014.
If you have any questions, please contact Regulatory Specialist at 610-219-4334 or Customer support at 610-219-6300.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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