BEUDAMED
    FDA Recall Terminated

    Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,Reno, NV 89502-Serial Numbers 2975 to 5360,

    Recall: Z-1249-06 · Initiated May 24, 2006

    Recall

    Recall Number
    Z-1249-06
    Event Number
    35592
    Firm
    Hamilton Medical Inc
    FEI Number
    2937708
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 24, 2006
    Posted
    July 22, 2006
    Terminated
    December 21, 2006
    Address
    4990 Energy Way P O Box 30008, Reno, NV, 89520-3008

    Description

    Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,Reno, NV 89502-Serial Numbers 2975 to 5360,

    Reason

    ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system.

    Action

    On May 24, 2006 the manufacturer initiated this recall. The Recalling establishment/US Initial Importer/Distributor-received the manufacturer''s notice on May 31, 2006 and initiated their recall on June 1, 2006. The US distributor has issued a Medical Device Field Correction.

    Distribution

    Worldwide

    Quantity

    2,385 for all models