BEUDAMED
    FDA Enforcement Class II Ongoing

    Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

    Recall: Z-0985-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0985-2020
    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 Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

    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

    225