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Philips Electronics North America Corp. recalls Philips HeartStart (HS1) Onsite/Home AED
Recalled May 30, 2018 · FDA recall Z-1914-2018 · Philips Electronics North America
Hazard
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed. · FDA Class II
Units
Total for FRx and HS1 - 660,519 defibrillators
Sold at
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.
Description
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
Product
Philips HeartStart (HS1) Onsite/Home AED
Manufacturer(s)
Philips Electronics North America Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →