BEUDAMED
    FDA Recall Terminated

    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis

    Recall: Z-1698-2017 · Initiated January 20, 2016

    Recall

    Recall Number
    Z-1698-2017
    Event Number
    76806
    Firm
    AGFA Healthcare Corp.
    FEI Number
    3001236302
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 20, 2016
    Posted
    March 29, 2017
    Terminated
    April 10, 2017
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis

    Reason

    The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.

    Action

    AGFA Healthcare sent an On January 20,2016, an 'URGENT FIELD SAFETY NOTICE" dated January 20, 2016, to all affected customers by email or sent via FedEx to the US and Canadian consignees. The notice included an acknowledgment form to be sent back. The letter described background information and actions. Customers with questions were instructed to call 1-877-777-2432 and reference PR1405160001-VR0000288. For questions regarding this recall call 864-421-1984.

    Distribution

    Worldwide Distribution - US including AL, AR, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OK, OR, RI, SC, TN, TX, VA, WV, WI, WY, and Internationally to Canada.

    Quantity

    308