BEUDAMED
    FDA Recall Terminated

    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.

    Recall: Z-2737-2018 · Initiated May 18, 2018

    Recall

    Recall Number
    Z-2737-2018
    Event Number
    80265
    Firm
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
    FEI Number
    3002809369
    Product Code
    ODI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 18, 2018
    Terminated
    August 4, 2020
    Address
    2568 Bristol Cir, Oakville Canada

    Description

    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.

    Reason

    Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may cause the cart s video pole to fail.

    Action

    The firm, Natus Neurology, notified its customers on approximately 05/18/2018 via an "URGENT: Medical Device Correction Notification" letter. Natus Neuro Technical Service will contact customers regarding sending this kit to their bio-medical engineering department. Kits are expected to be available the first week of June. If you have any questions regarding this correction, please contact our Technical Support Administrator by email at [email protected].

    Distribution

    United States Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV. Worldwide Distribution: Austria, Canada, Colombia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Israel, Japan, Jordan, Korea, ,Republic of Latvia, Malaysia, Oman, Philippines, Portugal, Saudi Arabia, Serbia, Slovenia, Switzerland. Sold To Location State AK AL AR AZ CA CO CT DC DE FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC TN TX UT VA VT WA WI WV Sold To Location State AK AL AR AZ CA CO CT DC DE FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC TN TX UT VA VT WA WI WV AK AL AR AZ CA CO CT DC DE FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC TN TX UT VA VT WA WI WV

    Quantity

    797 Total