Z-0642-2013Class II

Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems...

Name: Z-0642-2013 Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2012-07-26
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-07-26 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305... on 2012-07-26. FDA classified it as Class II and gives the reason as "Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or...". 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-0642-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-26
Posted: 2013-01-04
Terminated: 2020-09-21
Recalling firm: Philips North America LLC
Product: Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance o
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips Healthcare sent an Emergency Care and Resuscitation letter Customer Information Letter dated July 26, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Philip's representative to obtain the tools and information they need to ensure that their device is functioning properly. For questions regarding this recall, please call AED Recall Support at 1-800-263-3342 (Option 6).
Quantity in commerce: 201,598
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.
Product codes and lots: 1)Philips brand FRx Model Number 861304 under 510(k) K050004, sold nationally and Internationally, Serial numbers range from BO4L-00001 through B12F-00286 and represents 181,226 devices; 2) Laerdal brand FRx Model Number 861305 unfrt 510(k) K050004, sold nationally and Internationally, serial numbers range from B04L-00013 through B12E-04135 and represents 20,372 devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0642-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0642-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-04
Z-0643-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)