BEUDAMED
    FDA Recall Terminated

    Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.

    Recall: Z-0115-2015 · Initiated October 28, 2013

    Recall

    Recall Number
    Z-0115-2015
    Event Number
    66778
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    1000514697
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 28, 2013
    Posted
    October 22, 2014
    Terminated
    December 23, 2016
    Address
    2501 Barrington Rd, Hoffman Estates, IL, 60195-2061

    Description

    Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.

    Reason

    Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.

    Action

    Undated "Customer Safety Advisory Notice" letters were sent to all direct accounts (customers). The letters stated the problem, and included instructions for customers. Customers: 1) can continue to use the devices while waiting for an inspection to be scheduled and performed; and, 2) their local service engineer will inspect the detector pivot connections and make any necessary repairs on site. Customers with any questions can contact their local service representative or Siemens Molecular Imaging at 800-888-7436.

    Distribution

    Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the District of Columbia, Guam, and Puerto Rico; and, the countries of Albania, Algeria, Angola, Argentina, Austria, Australia, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cameroon, Canada, Chile, China, Columbia, Congo, Costa Rica, Cuba, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Madagascar, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, and Yemen.

    Quantity

    562 devices