Philips Medical Systems North America Co. Phillips: Medical Device Recall in 2013 - (Recall #: Z-0642-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 26, 2012

Date Posted: January 16, 2013

Recall Number: Z-0642-2013

Event ID: 63030

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

Status: Terminated

Product Quantity: 201,598

Code Information:

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.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.

Voluntary or Mandated:

Voluntary: Firm initiated