BEUDAMED
    FDA Recall Terminated

    Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.

    Recall: Z-1097-2013 · Initiated January 15, 2013

    Recall

    Recall Number
    Z-1097-2013
    Event Number
    64678
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 15, 2013
    Posted
    April 11, 2013
    Terminated
    April 23, 2013
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.

    Reason

    Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. This malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. This can re

    Action

    Siemens sent a Customer Safety Advisory letter dated January 15th, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The SIEMENS service representative will investigate if parts need to be exchanged in your product, an if so, which parts need to be exchanged to restore the system safety and function. Please kindly confirm receipt of the Field Safety Notice by sending back the attached form. For further questions please call (610) 448-3237.

    Distribution

    Nationwide Distribution including the states of CA, FL, GA, IA, IN, KS, LA, ME, MI, MO, NC, NH, NJ, NY, NV, OH, PA, TN, TX, VA and WA.

    Quantity

    51