BEUDAMED
    FDA Recall Terminated

    Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; ICS 3000 units are composed of three Catalog/Model Numbers: 349527, 349530, and 355547. The model 349530 is the component which is loaded/updated with software.

    Recall: Z-1373-2008 · Initiated January 10, 2007

    Recall

    Recall Number
    Z-1373-2008
    Event Number
    46751
    Firm
    Biotronik Inc
    FEI Number
    1028232
    Product Code
    MRM
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 10, 2007
    Posted
    July 29, 2008
    Terminated
    May 5, 2011
    Address
    6024 Jean Rd, Lake Oswego, OR, 97035-5308

    Description

    Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; ICS 3000 units are composed of three Catalog/Model Numbers: 349527, 349530, and 355547. The model 349530 is the component which is loaded/updated with software.

    Reason

    Timing Feature Error: An implementation error allows the usage of the V-V timing feature, which is not approved for use in the U.S.

    Action

    Consignees were notified by a letter sent 1/10/07. The letter advised users to stop usage of the affected software. Users were instructed not to implant additional devices until the software program has been corrected. The recalling firm requested that all affected software be scrapped or returned to them. Users were requested update the software with a corrected version as soon as it becomes available.

    Distribution

    Nationwide Distribution including states of AL, AZ, CA, CO, DE, FL, GA, IL, LA, MI, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TX and WA.

    Quantity

    53 of the 603.U discs distributed.