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
  • 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
  • 1 Event

Manufacturer

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