BEUDAMED
    FDA Recall Terminated

    AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager)

    Recall: Z-1421-2011 · Initiated January 14, 2011

    Recall

    Recall Number
    Z-1421-2011
    Event Number
    57775
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 14, 2011
    Posted
    February 23, 2011
    Terminated
    July 16, 2013
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager)

    Reason

    Firm became aware of a potential malfunction and possible hazard to patients in the event the tilt buttons on the OPTI Grip become stuck under the housing

    Action

    Siemens Medical Solutions USA, Inc issued a Customer Safety Advisory Notice via Update Instruction XP005/10/S to affected customers. This letter informs customers of the potential malfunction and of possible danger for patients, users or other persons. A future Update Instruction will be released for the replacement of the tilt buttons on all OPTI Grip handles. Customers were instructed to forward the safety notice to any new owners of this device and to provide Siemens Medical with names of the new customers. For any questions regarding this recall call 610-448-3237.

    Distribution

    Nationwide Distribution including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.

    Quantity

    1323