BEUDAMED
    FDA Enforcement Class II Terminated

    MyLab Gamma, Model 7410

    Recall: Z-0205-2019 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0205-2019
    Event ID
    81285
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ESAOTE S.P.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2018
    Initiation Date
    June 11, 2018
    Classification Date
    October 23, 2018
    Termination Date
    May 12, 2020
    Address
    Sesto Fiorentino, Via Degli Olmi 11, Sesto Fiorentino, N/A, N/A, Italy

    Description

    MyLab Gamma, Model 7410

    Reason

    The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.

    Code Info

    n/a

    Distribution

    Worldwide distribution - US Nationwide in the states of AK, AZ, CA, IN, MO, NM, PA, SC, and TX. and countries Argentina and Australia Austria Bangladesh Belgium Brazil Bulgaria China Costa Rica Denmark Egypt Finland France Germany Greece Hong Kong Hungary Iceland India Iran Italy Japan Kuwait Mexico Netherlands Norway Paraguay Poland Portugal Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Switzerland Taiwan Thailand Tunisia Turkey United Kingdom Utd.Arab Emir.

    Quantity

    10