BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated July 13, 2023

    Recall

    Recall Number
    Z-0159-2024
    Event Number
    93215
    Firm
    EMPATICA SRL Via Enrico Stendhal
    FEI Number
    3012933969
    Product Code
    POS
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 13, 2023
    Posted
    October 24, 2023
    Address
    36 Milan 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.

    Action

    Empatica S.r.l issued Field Safety Notice via email on 7/14/23. Letter states reason for recall, health risk and action to take: You can check your device lot number by: " From the Alert App On the home page of your MyEmbrace account on the right hand side of the screen you will see your Embrace Serial Number. The lot number is represented by the 5th, 6th and 7th digit of the serial number. " On the packaging of your device On the box that contained your Embrace2 there is an identification label (See picture below). The device Lot number is identified with the LOT symbol. In the picture below the device Lot number is F11. Empatica recommends that you pay increased attention to the product battery level notifications intended to inform you about the remaining battery charge. As noted in the user manual, the Embrace device is not intended to be used as a stand-alone monitoring device. As the system is not meant to substitute for ongoing seizure monitoring practices, patients are strongly advised to ensure that alternative methods of obtaining medical assistance are available at all times, including during device charging sessions Patients are also encouraged to contact Empatica customer support for any concern related to battery life impacting usability of the Embrace device. Customers contacted by the Empatica customer support team regarding battery duration are offered a free-of-charge replacement device.

    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