BEUDAMED
    FDA Recall Terminated

    The device is labeled as AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the Operating Room at Hospitals) and is labeled as ''MANUFACTURED FOR ARZCO MEDICAL SYSTEMS, INC. PO BOX 1048, TAMPA, FL 33601 1-800-231-6370 MODEL S/N''

    Recall: Z-0568-04 · Initiated October 27, 2003

    Recall

    Recall Number
    Z-0568-04
    Event Number
    27606
    Firm
    Cardiocommand Inc.
    FEI Number
    1927197
    Product Code
    LPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 27, 2003
    Posted
    July 20, 2004
    Terminated
    December 21, 2011
    Address
    4920 W Cypress St, Ste 110, Tampa, FL, 33607-3837

    Description

    The device is labeled as AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the Operating Room at Hospitals) and is labeled as ''MANUFACTURED FOR ARZCO MEDICAL SYSTEMS, INC. PO BOX 1048, TAMPA, FL 33601 1-800-231-6370 MODEL S/N''

    Reason

    The device may exhibit spurious heart rate increase during esophageal atrial pacing during simultaneous adjacent use of electrosurgical coagulation devices.

    Action

    The firm notified all user accounts and distributors by mailing a recall notifiation letter via certified first class mail on 10/31/2003 with a serial number list, photo of the device and a 'RECALL INFORMATION RETURN SHEET' for response. A second recall letter was sent out on January 15, 2004 via certified mail to all non responding accounts. The firms were asked to return recalled units, or identify the address of accounts they were transferred to and to notify these accounts.

    Distribution

    The devices under recall are at 142 domestic hospitals nationwide and to eight distributors in Canada, Hong Kong, the Netherlands, LA, HI, KY, AR and FL.

    Quantity

    307