BEUDAMED
    FDA Enforcement Class II Ongoing

    Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260

    Recall: Z-0980-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0980-2020
    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 Toco Transducer w/wing (2264LAX), FFCM3260

    Reason

    Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress.

    Code Info

    All serial numbers distributed between 02/06/16 - 04/30/19.

    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

    628