Terminated

Philips HeartStart FRx AED.

FDA Recall Z-1913-2018 · Posted None

Recalling FirmPhilips Electronics North America Corp.

Recall StatusTerminated

Product CodeMKJ

Date Initiated2018-03-14

Date Terminated2020-08-19

Product QuantityTotal for FRx and HS1 - 660,519 defibrillators

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050004PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304Philips Medical Systems · 2005-02-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.