BEUDAMED
    FDA Recall Terminated

    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

    Recall: Z-2178-2014 · Initiated July 16, 2014

    Recall

    Recall Number
    Z-2178-2014
    Event Number
    68844
    Firm
    AGFA Healthcare Corp.
    FEI Number
    3001236302
    Product Code
    IWZ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 16, 2014
    Posted
    August 10, 2014
    Terminated
    December 9, 2014
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

    Reason

    Some sheets of the medical screen film are fogged.

    Action

    On July 16, 2014, an "URGENT FIELD SAFETY NOTICE" letter was sent to the US and Canadian dealers (consignees). The letter described the safety alert and the request to quarantine affected product. Acknowledgment, via FAX-Back or email, that the information was received and understood was requested from the dealers. A customer Urgent Field Safety Notice was also provided to those dealers who had shipped affected product to end users so that it could be sent to their customers.

    Distribution

    Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada

    Quantity

    2617