BEUDAMED
    FDA Recall Terminated

    M3001A Philips Multi Measurement Server (MMS)

    Recall: Z-0183-2007 · Initiated September 21, 2006

    Recall

    Recall Number
    Z-0183-2007
    Event Number
    36489
    Firm
    Philips Medical Systems
    FEI Number
    1218950
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 21, 2006
    Posted
    November 16, 2006
    Terminated
    August 11, 2020
    Address
    3000 Minuteman Road, Andover, MA, 01810-1032

    Description

    M3001A Philips Multi Measurement Server (MMS)

    Reason

    Unexpected pulse oximetry (Sp02) readings (100%) over time when a sensor is not attached to the patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM

    Action

    Philips issued a Customer Letter and Urgent Device Correction letter to consignees on 09/21/06. Users were notified of the problem and provided with Instructions to Mitigate Risk. A software upgrade to: version D.00.61 and Sp02 FW A.01.46 is mandatory.

    Distribution

    Worldwide, including USA, Canada, Australia, China, Hong Kong, India, Indonesia, Japan, Phillipines, Singapore, Taiwan, Thailand, Vietnam, Argentina, Brazil, Chile, Colombia, El Salvador, Jamaica, Mexico, Nicaragua. Panama, Paraguay, Peru, Venezuela, Austria, Belgium, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Germany, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Lithuania, Luxembourg, Macedonia, Mauritania, Mauritius, Netherlands, Norway, Oman, Slovenia, South Africa, Spain, Switzerland, Turkey, UAE, UK, Yemen, Zambia, Zimbabwe

    Quantity

    69696 units