BEUDAMED
    FDA Enforcement Class II 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 · Reported August 15, 2018

    Enforcement

    Recall Number
    Z-2737-2018
    Event ID
    80265
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2018
    Initiation Date
    May 18, 2018
    Classification Date
    August 8, 2018
    Termination Date
    August 4, 2020
    Address
    2568 Bristol Cir, N/A, Oakville, N/A, N/A, 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.

    Code Info

    Catalog/Part Numbers: IP-EC-DT-CART; IP-EC- DT-CART-EXP, and part number 021240 which is a variation of IP-EC-DT-CART. All ErgoJust Carts that were shipped on or before 03/12/2018 are affected and included in this recall.

    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