Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Recalled by Philips Medical Systems North America Co. Phillips Due to Philips determined that it is important to clarify...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems North America Co. Phillips directly.
Affected Products
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.
Quantity: 201,598
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Medical Systems North America Co. Phillips
Philips Medical Systems North America Co. Phillips has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report