BEUDAMED
    FDA Recall Terminated

    ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH

    Recall: Z-0785-2014 · Initiated December 4, 2013

    Recall

    Recall Number
    Z-0785-2014
    Event Number
    67130
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    IZJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 4, 2013
    Posted
    January 17, 2014
    Terminated
    November 6, 2015
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH

    Reason

    The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment.

    Action

    On October 30, 2013 & December 4, 2013, the firm sent Urgent Medical Device Recall letters to their customers.

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AL, AR, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TN, TX, VA, VT, WA, WI & WV; and Internationally to: Austria, Belgium, Canada, Denmark, Germany, Great Britain, Italy, Netherlands, Norway, Pakistan, Russia, Singapore & South Korea.

    Quantity

    255 units