BEUDAMED
    FDA Enforcement Class II Terminated

    Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.

    Recall: Z-1945-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-1945-2012
    Event ID
    61807
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atom Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2012
    Initiation Date
    May 1, 2012
    Classification Date
    July 6, 2012
    Termination Date
    January 31, 2013
    Address
    3-18-15 Hongo, Bunkyo-Ku, N/A, Japan

    Description

    Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.

    Reason

    There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.

    Code Info

    All lots on the market of model 100

    Distribution

    Worldwide Distribution - USA including PA. Internationally to Japan, Kuwait, Saudi Arabia, Lenanon, Italy, Spain, China, East Europe, Slovakia, Poland, Czech Republic, Ukraine, Egypt, Russia, Algeria, Colombia, Germany, Malaysia, Switzerland, Australia, Europe, Portugal, Iran, Israel, Philippines, UAE, Korea, and Netherlands

    Quantity

    377 units