BEUDAMED
    FDA Enforcement Class II Ongoing

    Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660

    Recall: Z-0982-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0982-2020
    Event ID
    83869
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Pacific Medical Group Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    September 19, 2019
    Classification Date
    February 4, 2020
    Address
    212 Avenida Fabricante, N/A, San Clemente, CA, 92672-7538, United States

    Description

    Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660

    Reason

    Fetal transducers distributed in advance of receiving 510(k) and international clearances.

    Code Info

    All serial numbers sold between 01/21/2015 - 04/30/2019

    Distribution

    U.S.: IN, AZ, IL, HI, AK, AR, CA, FL, GA, IA, ID, LA, MA, NC, NE, NM, NY, OK, PA, TN, TX, UT, VA, WA, WV, NV, KY, CO, ME, ND, OH, SC, WI, AL, OR, DC, DE, MD, MI, MN, MO, MT, MS, NJ, NH. O.U.S. (Foreign): CA, CO, FR, GB, IT, MX, UAE

    Quantity

    4