BEUDAMED
    FDA Enforcement Class II Terminated

    ADVANTX LCA

    Recall: Z-0905-2017 · Reported January 4, 2017

    Enforcement

    Recall Number
    Z-0905-2017
    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 LCA

    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 00000048085YY5 706354SLCA 00000063506YY0 919443NGLCA Not Available 518761GLCA 00000052178YY1 914632LCA 00000052138YY5 740446LCA 00000063620YY9 843797LCA Not Available 414D1126 00000034252YY7 YX0950

    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)