BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A

    Recall: Z-0078-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0078-2022
    Event ID
    88637
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 20, 2021
    Initiation Date
    February 9, 2021
    Classification Date
    October 8, 2021
    Address
    22100 Bothell Everett Hwy, N/A, Bothell, WA, 98021-8431, United States

    Description

    Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A

    Reason

    Customers were not notified of previous recalls associated with various defibrillator models.

    Code Info

    Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514

    Distribution

    U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.

    Quantity

    4 units