BEUDAMED
    FDA Recall Terminated

    TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)

    Recall: Z-1453-06 · Initiated April 7, 2006

    Recall

    Recall Number
    Z-1453-06
    Event Number
    35696
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    KLK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 7, 2006
    Posted
    August 29, 2006
    Terminated
    April 25, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)

    Reason

    System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further.

    Action

    The firm began a recall/corrective action in response to this component defect on 4/7/2006, at which time, the firm issued a Field Action Notes memo (915-234). The firm is having their representatives: 1) assure that the use of the CompactFlashcards manufactured by Simple Tech has been discontinued at each customer location; 2) Replaace the CompactFlash card in all basic Units, 391-876, of R0036 through R0043; and 3) replace any spare part #914-698, which has been installed in Basic Units, 391--876, below R0036. Once completed, the firm has supplied their customers with a TELEFAX form to be completed, signed and dated by each customerand faxed back to Radiometer Medical ApS. The form documents that the instructions provided in theField Action Notes have been followed and that the necessary component replacements have been completed. The firm anticipates that the necesary corrective action will be completed by 7/1/2006.

    Distribution

    Worldwide-The recalled product was distributed to customers throughout the U.S. and Canada.

    Quantity

    61 in U.S. 7 in Canada