BEUDAMED
    FDA Recall Terminated

    Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97 016; Siemens Medical Solutions USA, Concord, CA 94520

    Recall: Z-0284-2008 · Initiated February 27, 2007

    Recall

    Recall Number
    Z-0284-2008
    Event Number
    45495
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    KPQ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 27, 2007
    Posted
    January 31, 2008
    Terminated
    February 3, 2011
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97 016; Siemens Medical Solutions USA, Concord, CA 94520

    Reason

    Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.

    Action

    Customers were sent a Customer Safety Advisory Notice on February 27, 2007, notifying them that the mounting screws on the cassette holders on the SIMVIEW 3000 and NT Simulators, as well as some MEVASIM Simulators, could loosen and can cause damage to the system, or personal injury. The firm requested that they check of tightness on the mounting hardware. A STOP Modification notice was issued on 06/01/2007, to all affected regional service organizations that are responsible for implementing updates due to new information. Updated letters and User instructions will be released in August 2007.

    Distribution

    Worldwide Distribution - USA including states of IN, VA, MA, VT, NJ, NY, PA, DC, NC, SC, GA, AL, TN, MI, KY, OH, IN MI, MN, ND, MT, IL, MO, KS, NE, AR, OK, TX, AZ, CA, SD, LA, Puerto Rico, and countries of Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Croatia, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Iran, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, China, Israel/Palestine, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, UK, and Vietnam.

    Quantity

    287 units total, all recalls Z-0281-285-2008