Events

Recall of Device Recall The Ysio Systems with software version VC10

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69148
  • Event Risk Class
    Class 2
  • Event Number
    Z-2680-2014
  • Event Initiated Date
    2014-08-27
  • Event Date Posted
    2014-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129747
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, stationary - Product Code KPR
  • 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.
  • 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.

Device

Device Recall The Ysio Systems with software version VC10
  • Model / Serial
    Model numbers: 10281013, 10281163.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    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.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA