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Z-1914-2018 Class II Terminated

Recalled by Philips Electronics North America Corp. — Bothell, WA

FDA device recall Z-1914-2018 was initiated by Philips Electronics North America Corp. on March 14, 2018 and is designated Class II. Reason for recall: An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed. The recall status is terminated (terminated August 19, 2020). Affected quantity: Total for FRx and HS1 - 660,519 defibrillators.

Recall Details

Product Type: Devices
Report Date: May 30, 2018
Initiation Date: March 14, 2018
Termination Date: August 19, 2020
Voluntary/Mandated: FDA Mandated
Product Quantity: Total for FRx and HS1 - 660,519 defibrillators

Product Description

Philips HeartStart (HS1) Onsite/Home AED

Reason for Recall

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

Distribution Pattern

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.

Code Information

Manufactured between September 2002 and February 2013. The year of manufacture can be identified by the 2nd and 3rd characters in the serial number on the back of the AED in the following ranges: Home/Onsite: A02x-xxxxx through A13B-xxxxx; FRx: B04x-xxxxx through B13B-xxxxx NOTE: If the device was manufactured in 2013 and the 4th digit is the letter "C" or later (D, E, F...), it is not covered by the recall (i.e. A13G-02375). In some cases, a device within the date range covered by the notification did not contain a resistor previously associated with a failure. In that case, a notification was not sent. Confirmation as to whether the device contains the resistor at issue can be done by contacting the firm.