BEUDAMED
    FDA Recall Terminated

    Philips HeartStart FRx AED.

    Recall: Z-1913-2018 · Initiated March 14, 2018

    Recall

    Recall Number
    Z-1913-2018
    Event Number
    79343
    Firm
    Philips Electronics North America Corp.
    FEI Number
    1000524572
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 14, 2018
    Terminated
    August 19, 2020
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Philips HeartStart FRx AED.

    Reason

    An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.

    Action

    Letters dated 2/16/2018 for U.S. customers were issued via certified mail on 3/14/2018. Letters to customers outside of the U.S. were localized in conjunction with the local Philips market organizations and are in progress.

    Distribution

    Distribution was nationwide and to Puerto Rico. There was also government/military distribution. Foreign distribution was made to the following countries: Canada, Afghanistan, Algeria, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Brunei Darussalam, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Fiji, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Malaysia, Malta, Mauritius, Mexico, Morocco, Namibia, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Niger, Norway, Oman, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirate, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia, and Zimbabwe.

    Quantity

    Total for FRx and HS1 - 660,519 defibrillators