BEUDAMED
    FDA Recall Terminated

    Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.

    Recall: Z-1753-2019 · Initiated March 29, 2019

    Recall

    Recall Number
    Z-1753-2019
    Event Number
    82668
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    KXJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 29, 2019
    Posted
    June 10, 2019
    Terminated
    April 15, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.

    Reason

    There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

    Action

    On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers were instructed to do the following: Please follow the precautions below until the monitor feet on your unit are replaced: -The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use. -Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service representative. -Monitor should not be positioned directly above the patient. -Before service or preventative maintenance of the monitor is attempted, review the service and preventive maintenance procedures. Also the customer were instructed to complete and return the MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED form by scanning or taking a photo of the completed form e-mailing to: [email protected]. F/U visits by GE Healthcare will be made to replace the plastic feet. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France, French Polynesia, Germany, Greece, Guadeloupe, Guyana, Hungary, Italy, Japan, Korea, Lebanon, Mexico, Morocco, New Caledonia, Norway , Poland, Portugal, Russia, Saudi Arabia,Slovakia, Spain, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam.

    Quantity

    825 (38 US and 787 OUS) in total