BEUDAMED
    FDA Enforcement Class II Terminated

    ADVANTX LCN+

    Recall: Z-0907-2017 · Reported January 4, 2017

    Enforcement

    Recall Number
    Z-0907-2017
    Event ID
    75851
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 4, 2017
    Initiation Date
    November 21, 2016
    Classification Date
    December 23, 2016
    Termination Date
    September 26, 2017
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    ADVANTX LCN+

    Reason

    GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.

    Code Info

    Mfg. Lot or Serial # System ID 00000089619MO1 205592MLC 00000089632MO4 205592MLC 00000052196YY3 601459LC 00000023729YY7 910343NHC1 00000031441YY9 603668CLC3 00000034211YY3 603668CLC3 00000034271YY7 973429CATH Not Available 215576LC2 Not Available 610250SC Not Available 0910062022 Not Available 0910062022 00000023777YY6 1025 00000026231YY1 3919-1 00000023841YY0 93162 00000023841YY0 93162 Not Available GOLD000540

    Distribution

    US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hungary Iceland India Ireland Italy Japan Korea Libya Mexico Netherlands Netherlands Peru Poland Portugal Russia Saudi Arabia Serbia Sierra Leone Slovakia Spain Taiwan Thailand Turkey United Arab Emirates United Kingdom Venezuela Vietnam

    Quantity

    Total for all products 1,598 (USA 824, OUS 774)