Events

Recall of Device Recall Sonialvision Safire II, Model : DAR8000f

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Shimadzu Medical Systems.

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
    80067
  • Event Risk Class
    Class 2
  • Event Number
    Z-2060-2018
  • Event Initiated Date
    2018-01-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164342
  • 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, angiographic - Product Code IZI
  • Reason
    When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the x-ray generator console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. there has been one report of this event.
  • Action
    Shimadf0u sent an Urgent Voluntary Medical Device Recall Notice letter dated January 2018. The letter identified the affected product, problem and actions to be taken. For questions contact Shimadzu representative or contact Shimadzu National Technical Support at 800-228-1429.

Device

Device Recall Sonialvision Safire II, Model : DAR8000f
  • Model / Serial
    Serial #: 0161G68101, 0261G65303, 0261G65702, 0261G68204, 3M72BFB21001, 3M72BFB2A001, 3M72BFC2A001, 3M72BFC2C001, 3M72BFB32001, 3M72BFB32006, 3M72BFB33003,3M72BFC33001, 3M72BFC34001, 3M72BFB35005, 3M72BFC37002, 3M72BFC42001, 3M72BFB46002
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
  • Product Description
    Sonialvision Safire II, Model #: DAR-8000f || Product Usage: || This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.
  • Manufacturer
    Shimadzu Medical Systems

Manufacturer

Shimadzu Medical Systems
  • Manufacturer Address
    Shimadzu Medical Systems, 20101 S Vermont Ave, Torrance CA 90502-1328
  • Manufacturer Parent Company (2017)
    Shimadzu Corp.
  • Source
    USFDA