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.
This recall has been terminated (originally issued September 23, 2014).
- Recall Initiated
- August 27, 2014
- Posted
- September 23, 2014
- Terminated
- March 30, 2015
- Recall Number
- Z-2680-2014
- Quantity
- 62
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Model numbers: 10281013, 10281163.
Root Cause
Under Investigation by firm
Action Taken
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.