—#129747

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.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K081722
Affected lot / code info: Model numbers: 10281013, 10281163.

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2014-08-27
Posted by FDA: 2014-09-23
Terminated: 2015-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129747. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.