BEUDAMED
    FDA Enforcement Class II Terminated

    Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.

    Recall: Z-0050-2014 · Reported October 30, 2013

    Enforcement

    Recall Number
    Z-0050-2014
    Event ID
    66361
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Convergent Dental
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 30, 2013
    Initiation Date
    September 12, 2013
    Classification Date
    October 22, 2013
    Termination Date
    November 15, 2013
    Address
    2 Vision Dr, N/A, Natick, MA, 01760-2086, United States

    Description

    Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.

    Reason

    Specific error condition could lead to unintended laser emission during laser activation.

    Code Info

    Serial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13

    Distribution

    US distribution including states of: MA, CT, NY.

    Quantity

    5