Recall Z-2680-2014 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
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.
| Date | Sep 23, 2014 (initiated Aug 27, 2014) |
| Status | Terminated |
| 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. |
| 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 upgrad |
| Quantity | 62 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081722 | YSIO Siemens Medical Solutions USA, Inc., Aug 22, 2008 |