BEUDAMED
    FDA Recall Terminated

    Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8, Manufactured by GE Hangwei Medical Systems Co., LTD, Beijing PR, China

    Recall: Z-0170-2008 · Initiated December 31, 2006

    Recall

    Recall Number
    Z-0170-2008
    Event Number
    45491
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    December 31, 2006
    Posted
    November 7, 2007
    Terminated
    December 11, 2007
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8, Manufactured by GE Hangwei Medical Systems Co., LTD, Beijing PR, China

    Reason

    Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.

    Action

    Field Modification Instruction : FMI 67631 (DEC 2006) was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. Corrections were performed in DEC 2006

    Distribution

    Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MO, MS, MT, NJ, NY, OH, OK, PA, SD, VA, and WA, and countries of United Arab Emirats, Argentina, Belgium, Brazil China, Ivery Cost, Germany, Spain, France, United Kingdom, Hungary, Italy, Japan, Korea, Mexico, Oman, Panama, Puerto Rico, Russia, and Turkey

    Quantity

    163