Device Recall GammaMed Plastic Needle with Mandrin

  • Model / Serial
    Part numbers GM11007580;  All lots C01 to D01 and lots H and I
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Austria, Bangladesh, Belgium, Brazil, Canada, Columbia, Cyprus, Czech Republic Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, India, Japan, Kazahastan, Kuwait, Lebanon, Macedonia, Mexico, Moldova, Nepal New Zealand, Norway, Pakistan, Philippines, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Arab Emirates Uruguay, United Kingdom, and Venezuela.
  • Product Description
    GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 320 mm. || Remote controlled radionuclide applicator system. || Varian Medical Systems, Inc. || Mfg by Varian Medical Systems Haan GmbH, Haan, Germany || Product Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin
  • 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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Part numbers GM11007560;  All lots C01 to D01 and lots H and I
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Austria, Bangladesh, Belgium, Brazil, Canada, Columbia, Cyprus, Czech Republic Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, India, Japan, Kazahastan, Kuwait, Lebanon, Macedonia, Mexico, Moldova, Nepal New Zealand, Norway, Pakistan, Philippines, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Arab Emirates Uruguay, United Kingdom, and Venezuela.
  • Product Description
    GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. || Remote controlled radionuclide applicator system. || Varian Medical Systems, Inc. || Mfg by Varian Medical Systems Haan GmbH, Haan, Germany || Product Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin
  • Manufacturer
  • Model / Serial
    Part numbers GM11007570;  All lots C01 to D01 and lots H and I
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Austria, Bangladesh, Belgium, Brazil, Canada, Columbia, Cyprus, Czech Republic Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, India, Japan, Kazahastan, Kuwait, Lebanon, Macedonia, Mexico, Moldova, Nepal New Zealand, Norway, Pakistan, Philippines, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Arab Emirates Uruguay, United Kingdom, and Venezuela.
  • Product Description
    GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 200 mm. || Remote controlled radionuclide applicator system. || Varian Medical Systems, Inc. || Mfg by Varian Medical Systems Haan GmbH, Haan, Germany || Product Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin
  • Manufacturer