BEUDAMED
    FDA Recall Terminated

    Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units configured with the appropriate options can also simultaneously monitor temperature and noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and continuously monitor pulse rate. The monitor provides programmable audible and visual alarms and automatic NIBP measurements at selectable intervals.

    Recall: Z-1873-2009 · Initiated July 28, 2009

    Recall

    Recall Number
    Z-1873-2009
    Event Number
    52721
    Firm
    Welch Allyn Protocol, Inc
    FEI Number
    3023750
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 28, 2009
    Posted
    July 30, 2009
    Terminated
    August 10, 2011
    Address
    8500 Sw Creekside Pl, Beaverton, OR, 97008

    Description

    Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units configured with the appropriate options can also simultaneously monitor temperature and noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and continuously monitor pulse rate. The monitor provides programmable audible and visual alarms and automatic NIBP measurements at selectable intervals.

    Reason

    The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms.

    Action

    An "Urgent: Correction" letter dated July 28, 2009 was sent to customers describing the risk associated with loss of audible alarms and recommend that the users mitigate the risk by checking for proper audible alarm function each time they power on the device. (Current labeling describes the variety of beeps and tones that should be present). Users were instructed: 1) if the audio fails, do not use the device, 2) Remove it from service and 3) contact Welch Allyn Protocol, Inc. at the following telephone number (1-800-289-2501) to arrange the return and repair of your device to Technical Services. Direct questions about this recall to Welch Allyn Protocol, Inc. by calling 1-503-530-7935.

    Distribution

    Worldwide Distribution -- US, United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Bulgaria, Bahrain, Botswana, Canada, Switzerland, China, Cyprus, Germany, Denmark, Egypt, Spain, Figi, France, Great Britain, Greece, Hong Kong, Croatia, Indonesia, Ireland, Israel, India, Iceland, Italy, Jordan, Kenya, Kyrgyzstan, South Korea, Kuwait, Lebanon, Sri Lanka, Malaysia, Nigeria, The Netherlands, Norway, New Zealand, Oman, Phillipines, Pakistan, Poland, Puerto Rico, Panama, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Thailand, Taiwan and South Africa.

    Quantity

    68,123