Events

Recall of Siemens YSIO solid state xray imager

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
    58897
  • Event Risk Class
    Class 2
  • Event Number
    Z-2787-2011
  • Event Initiated Date
    2011-04-28
  • Event Date Posted
    2011-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100488
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    There is a potential hazard to staff or patients when lowering the table height on the ysio system. if staff or patients lower extremities are placed underneath the table and the user lowers the table top, it is possible that parts of the table may collide with extremities and cause injuries.
  • Action
    Siemens sent a Safety Advisory Notice to all affected customers. The Safety Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to place the Safety Notice in the System's instruction for use. If product was distributed further, customers were to forward the safety notice to the new owner and inform the firm of the new owner. Customers were instructed to complete the Acknowledgement of Receipt Form and return to the firm.

Device

Siemens YSIO solid state xray imager
  • Model / Serial
    Model numbers 10281013 and 10281163. Serial numbers 30080, 20045, 31072, 31060, 31064, 21065, 31017, 21086, 31040, 30038, 30047, 21088, 30030, 20034, 20112, 21006, 21139, 20093, 20110, 21066, 21031, 20155, 30024, 30055, 21112, 21114, 21122, 31069, 30051, 30076, 31012, 21076, 21077, 31010, 31011, 31018, 31059, 20088, 20089, 20106, 20107, 21052, 31071, 31075, 30032, 31004, 31026, 31108, 21094, 21103, 30078, 20167, 21089, 21098, 21101, 30062, 31019, 31053, 31054, 31077, 31081, 31094, 21085, 30050, 21057, 31093, 31046, 21116, 21117, 21118, 21120, 30021, 31028, 21091, 21123, 21092, 21037, 31001, 30029, 30040, 20149, 21163, 21171, 21172, 21173, 31066, 31067, 30063, 30066, 30067, 31078, 20094, 30052, 21115, 21113, 31003, 20047, 31079, 20193, 31095, 31103, 31104, 31047, 30019, 30023, 30027, 30037, 20118, 21039, 21040, 21108, 31082, 30033, 21100, 30034, 20105, 20115, 20035, 30073, 20185, 21061, 31037, 21095, 21148, 31114, 20184, 21167, 21140, 21175, 21023, 21001, 21004, 21005, 21127, 31096, 31014, 31043, 31045, 21013, 20159, 21160.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Washington, DC and the following States: AR, CA, CO, FL, ID, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
  • Product Description
    Siemens YSIO - solid state x-ray imager || Solid state x-ray imager (flat panel/digital imager), image-intensified fluoroscopic x-ray system
  • 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