BEUDAMED
    FDA Recall Terminated

    Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

    Recall: Z-0110-2015 · Initiated October 7, 2014

    Recall

    Recall Number
    Z-0110-2015
    Event Number
    69467
    Firm
    Mortara Instrument, Inc
    FEI Number
    2183461
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 7, 2014
    Posted
    October 22, 2014
    Terminated
    February 13, 2015
    Address
    7865 N 86th St, Milwaukee, WI, 53224-3431

    Description

    Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

    Reason

    Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors. If the mounting screws provided by Mortara are not used and if the mounting screws used are longer than the p

    Action

    Mortar Instruments, Inc. sent an "Urgent Medical Device Correction" letter dated October 3, 2014. The letter was addressed to Health Care Administrator / Risk Manger and Director of Biomedical / Clinical Engineering.The letter described the problem and the product involved in the recall. Customers were advised to contact Mortara Technical Support at 1-888-667-8272 or TechSupport @mortara.com to schedule a service representative to update their Surveyor S12 and Surveyor S19 units or for additional questions they can contact their local Service Representative. The update will include replacement of the battery cover and replacement of the battery pack if mounting screw damage is evident. International consignees received similar dated letter except it provided instructions detailing the correction steps and requested customers to complete and return the Response Acknowledgement and Receipt Form. For questions they can contact Technical Support at +1.414.354.1600 or [email protected], or contact your local Service Representative.

    Distribution

    Worldwide Distribution: US (Nationwide) in the states of: AZ, AR, CA, DC, FL, ID, IL IN, KY, LA, ME, MD, MA, MI, MN, MO, MT, NV, NJ, NY, NC, OK PA, SC, TN, TX, VA, and WI; and internationally to: AUSTRALIA, BANGLADESH, CANADA, CHILE, CROATIA, EGYPT, GERMANY, ITALY, JORDAN, LEBANON, MALAYSIA, MOROCCO, OMAN, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, THAILAND, THE NETHERLANDS, UNITED KINGDOM.

    Quantity

    624