Device Recall GammaMed Flexible Applicator

  • Model / Serial
    Lots D01 to H14; Part number GM1102560
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide (USA) and including the countries of France, Germany, India, Trinidad and Tobago, United Kingdom, Canada, Nepal, Ukraine, Czech Republic, Bangladesh, Thailand, Turkey, Brazil, Estonia, Switzerland, Russia, Greece, Philippines, Spain, Belgium, Kuwait, Romania, Morocco, Mexico, Columbia, Austria, Poland, Kazahstan, Vietnam, Cyprus, New Zealand, Dominican Republic, Norway, Uzebestan, Hungary, Lebanon, South Africa, South Korea, Slovenia, Venezuela, Serbia, Tunisia, Pakistan, Macedonia, Ireland, Azerbajian, Ukraine, Morroco, Italy, Singapore, Nambia, Turkey, Sudan, and Taiwan.
  • Product Description
    GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF. || Varian Medical Systems, Palo Alto, CA. || Mfg by Varian Medical Systems, Haan GmbH. || Flexible Applicator Robes are designed for brachytherapy intracavitary treatments in areas such as vagina, vagina stump or rectum.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
  • Source
    USFDA