BEUDAMED
    FDA Recall Terminated

    Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and neuro systems.

    Recall: Z-0426-2011 · Initiated August 23, 2010

    Recall

    Recall Number
    Z-0426-2011
    Event Number
    56380
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 23, 2010
    Posted
    November 19, 2010
    Terminated
    July 13, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and neuro systems.

    Reason

    If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.

    Action

    Consignees were sent on 8/23/10 a GE "Urgent Medical Device Correction" letter dated August 20, 2010. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Customers were asked to discontinue use of their MR system and to contact their local service representative, if the lateral table adjustment crank handle on the table becomes loose.

    Distribution

    Worldwide Distribution -- USA, including states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, KS, KY, LA, MD, MA, MI, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WV, and WI and countries of VENEZUELA, ECUADOR, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, SPAIN, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PHILIPPINE,S OMAN, MEXICO, KUWAIT, JAPAN, ITALY, HUNGARY, GERMANY, EGYPT, DENMARK, CHILE, CHINA, and BRASIL.

    Quantity

    202