BEUDAMED
    FDA Recall Terminated

    RapidScreen RS-2000D, Medical Image Analyzer.

    Recall: Z-1173-06 · Initiated May 4, 2006

    Recall

    Recall Number
    Z-1173-06
    Event Number
    35456
    Firm
    Riverain Medical Group
    FEI Number
    3005156333
    Product Code
    MYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 4, 2006
    Posted
    June 27, 2006
    Terminated
    February 20, 2013
    Address
    3020 S Tech Blvd, Miamisburg, OH, 45342-4860

    Description

    RapidScreen RS-2000D, Medical Image Analyzer.

    Reason

    The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity.

    Action

    The recalling firm sent a letter dated 5/4/06 to medical facilities, sent a letter dated 5/5/06 to distributors, and sent a letter dated 5/10/06 to GE Healthcare, Waukesha, WI.

    Distribution

    Nationwide. The product was distributed to consignees located in IL, CA, MO, CO, WA, MT, ID, OR, NC, TX, TN, FL, UT, MN, OK, WI, OH, AZ, IA, and PA.

    Quantity

    29 devices