BEUDAMED
    FDA Enforcement Class II Ongoing

    Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

    Recall: Z-0159-2024 · Reported November 1, 2023

    Enforcement

    Recall Number
    Z-0159-2024
    Event ID
    93215
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    EMPATICA SRL
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 1, 2023
    Initiation Date
    July 13, 2023
    Classification Date
    October 24, 2023
    Address
    Via Enrico Stendhal 36, N/A, Milan, N/A, N/A, Italy

    Description

    Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

    Reason

    May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.

    Code Info

    UDI-DI: (1) Flamingo Pink EM2-FP-S - 00853858006133; (2) Sky Blue EM2-SB-2 - 00853858006140; (3) Seoul Grey EM2-SG-S - 00853858006126; (4) Boston Blue EM2-BB-S - 00853858006119; (5) Milan Black EM2-MB-S - 00853858006102 Lot Numbers: G11/H11

    Distribution

    Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.

    Quantity

    1360 units