BEUDAMED
    FDA Recall Terminated

    IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A

    Recall: Z-1487-06 · Initiated July 24, 2006

    Recall

    Recall Number
    Z-1487-06
    Event Number
    35785
    Firm
    Philips Medical Systems
    FEI Number
    1218950
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 24, 2006
    Posted
    September 12, 2006
    Terminated
    August 11, 2020
    Address
    3000 Minuteman Road, Andover, MA, 01810-1032

    Description

    IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A

    Reason

    Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached

    Action

    Philips is using the contract services of Sterling, Indianapolis, IN to contact all consignees regarding the correction/upgrade to the device. The letter notification dated 7/21/06 was mailed UPS Delivery Tracking the week of 07/24/06. Additionally, Philips included with the Urgent Device Correction Notice a procedure to mitigate risk until the upgrade is installed.

    Distribution

    Worldwide, including USA, Canada, Argentina, Australia, Austria, Belgium, Brazil, Czech, Croatia, China, Denmark, Finland, France, Germany, Israel, Italy, Jordan, Kuwait, Luxemburg, Netherlands, Oman, Norway, Poland, Portugual, Poland, Russia, South Africa, Spain, Sweden, Swizerland, Turkey, UAE, Yemen, UK, Zimbabwe, Zambia, India, Indonesia, Japan, Korea, Philipines, Malaysia, Singapore, Sri Lanka, Taiwan, Vietnam, Venezuela.

    Quantity

    48,699 units