BEUDAMED
    FDA Recall Terminated

    Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer

    Recall: Z-1506-2012 · Initiated February 22, 2012

    Recall

    Recall Number
    Z-1506-2012
    Event Number
    61517
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 22, 2012
    Posted
    May 10, 2012
    Terminated
    January 24, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer

    Reason

    There is a potential malfunction in the connection of a Sensis EP system with Carto(R) 3 dedicated cable set (part number 14411343) with the Carto 3 system from Bionsense Webster.

    Action

    Siemens sent a recall/correction letter dated February 22, 2012, via Update Instruction AX049/11/S of this product to all affected customers. The letter informed customers of the potential issues and provides additional information on the implemented resolution. An Update Instuction AX048/11/S will be available immediately. The update instruction provides a new version of the Carto 3 addendum to the Operator Manual and the exchange of the previous stim cables with the latest cable. For questions call 610-219-4834.

    Distribution

    Nationwide Distribution including FL, NC, and SC.

    Quantity

    3