Sopha Medical Vision DST / DSTXL Nuclear Cameras

  • Model / Serial
    Cameras affected by this safety notice are labeled with the SOPHA MEDICAL logo. STATIF DST and STATIF DST-XL model 100, serial numbers 001-264. The label is located on the inner side of the gantry cover. All affected cameras were manufactured prior to 1997 by Sopha Medial (SMV), which was subsequently acquired by GE Healthcare in 2000.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Within the US to include: AL, AZ, CA, DE, FL, GA, IA, IL, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, VA, WI and WV. OUS to include: Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Greece, Italy, Korea, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sinapore, Spain, Sweden and United Kingdom
  • Product Description
    Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA