Z-1913-2018Class II

Philips HeartStart FRx AED

Name: Z-1913-2018 Philips HeartStart FRx AED
Creator: Philips Electronics North America Corp.
Published: 2018-03-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-03-14 / Terminated / root cause: manufacturing process

FDA source

Philips Electronics North America Corp. began a recall of Philips HeartStart FRx AED on 2018-03-14. FDA classified it as Class II and gives the reason as "An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1913-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-14
Posted: 2018-05-23
Terminated: 2020-08-19
Recalling firm: Philips North America LLC
Product: Philips HeartStart FRx AED.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: Total for FRx and HS1 - 660,519 defibrillators
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1913-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1913-2018	Class II	Terminated	FDA Mandated	2018-05-30	2018-05-23
Z-1914-2018	Class II	Terminated	FDA Mandated	2018-05-30	2018-05-23

Product code MKJ

K050004Class IIIPhilips Heartstart Frx Defibrillator, Model 861304Philips Medical Systems / cleared 2005-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)