BEUDAMED
    FDA Recall Terminated

    AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).

    Recall: Z-0565-06 · Initiated January 12, 2003

    Recall

    Recall Number
    Z-0565-06
    Event Number
    34472
    Firm
    Inovise Medical, Inc.
    FEI Number
    3003264460
    Product Code
    DPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2003
    Posted
    March 3, 2006
    Terminated
    July 24, 2006
    Address
    10565 Sw Nimbus Ave, Ste 100, Portland, OR, 97223-4311

    Description

    AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).

    Reason

    Use of the AUDICOR 200 D in-line with a defibrillator/monitor resulted in interruption of pacing therapy to a patient when the AUDICOR 200 D stopped working due to low battery power.

    Action

    On January 12, 2006, 2 of 3 customers were notified by telephone, with follow-up email. All three customers were visited by the firm on January 16-17, 2006. Customers were instucted to not use the device in-line with a defibrillator/monitor.

    Distribution

    Product distributed to three EMS/Fire Departments located in Florida and Washington

    Quantity

    28 units