BEUDAMED
    FDA Recall Terminated

    GE Healthcare Infinia, Model Numbers: ASM000886, ASM001391, ASM001333, ASM001465, ASM001473, ASM001620, ASM500016, H3000WM, H3000WT, H3000WY and SYS000041. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.

    Recall: Z-1001-2009 · Initiated June 2, 2008

    Recall

    Recall Number
    Z-1001-2009
    Event Number
    50918
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 2, 2008
    Posted
    April 21, 2009
    Terminated
    May 24, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Infinia, Model Numbers: ASM000886, ASM001391, ASM001333, ASM001465, ASM001473, ASM001620, ASM500016, H3000WM, H3000WT, H3000WY and SYS000041. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.

    Reason

    GE Healthcare has recently became aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety. It was reported at a customer site that the pressure used to activate the Pressure Sensitive Device (PSD) should be lowered and that the body contouring software requires correction to prevent po

    Action

    Consignees were sent from June 2008 to February 2009 a GE "Product Safety Notification" letter dated April 2008. The letter was addressed to Hospital Administrators and Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. A GE Healthcare service representative will contact each consignee to schedule the installation of the Pressure Sensitive Device (PSD). Please contact your local sales or service representative for further information regarding this recall. Further information can be found by calling 1-800-437-1171 in the US or Canada or 1-262-896-2890 if outside the US.

    Distribution

    Worldwide Distribution US (and Puerto Rico) including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV and WI and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungry, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Georgia, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine and the United Kingdom.

    Quantity

    365 US, 408 OUS