BEUDAMED
    FDA Recall Terminated

    TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)

    Recall: Z-1437-06 · Initiated February 2, 2005

    Recall

    Recall Number
    Z-1437-06
    Event Number
    35700
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    KLK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 2, 2005
    Posted
    August 30, 2006
    Terminated
    May 9, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)

    Reason

    Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped.

    Action

    The firm initiated a recall action for the suspect device with a letter dated 2/2/2005. During a site visit to the U.S. customers conducted by the firm''s Field Service reps, the reps informed the user/customers of this problem and requested that all use of the device be discontinued, pending the formulation of a more permanent solution. Beginning on 2/8/2005, a second site visit was made to the same user/customers, at which time, the affected units were upgraded with operating software version 2.12. The firm''s recall/corrective action was scheduled for completion by 3/1/2005.

    Distribution

    Nationwide

    Quantity

    9 monitors were distributed.