Z-2680-2014Class II

The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the...

Name: Z-2680-2014 The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-08-27
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-08-27 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and... on 2014-08-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2680-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-27
Posted: 2014-09-23
Terminated: 2015-03-30
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: KPR System, X-Ray, Stationary
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 62
Distribution: Nationwide Distribution.
Product codes and lots: Model numbers: 10281013, 10281163.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2680-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2680-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23

Product code KPR

K081722Class IIYsioSiemens Medical Solutions USA, Inc. / cleared 2008-08-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)