FDA-Device2018-05-30Class II
Philips HeartStart FRx AED.
Philips Electronics North America Corp.
Hazard
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
Sold states
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.
Affected count
Total for FRx and HS1 - 660,519 defibrillators
Manufactured in
22100 Bothell Everett Hwy, N/A, Bothell, WA, United States
Products
Philips HeartStart FRx AED.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1913-2018Don't want to check this manually?
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