BEUDAMED
    FDA Enforcement Class II Terminated

    Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

    Recall: Z-1432-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1432-2018
    Event ID
    79451
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 25, 2018
    Initiation Date
    March 16, 2018
    Classification Date
    April 18, 2018
    Termination Date
    April 10, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

    Reason

    Potential risk for helium gas inside the MR examination room during a magnet quench

    Code Info

    (Added 6/25/18): 7149 7210 7082 7212 7015 7174 7081 10327 7073 10332 7063 7040 7119 7095 7272 10104 7005 7213 7057 10326 7128 10339 7230 10329 7183 7098 10053 7080 7011 7178 7139 7126 10192 7217 7066 7171 7136 7038 7050

    Distribution

    Worldwide Distribution - US Nationwide; International - Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Chile, China, Colombia, Congo (Democratic Republic of the), Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Republic of Korea - South Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lesotho, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mauritius, Mexico, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Yemen & Zimbabwe.

    Quantity

    8,205 units in total