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.
This recall has been terminated (originally issued January 4, 2013).
- Recall Initiated
- July 26, 2012
- Posted
- January 4, 2013
- Terminated
- September 21, 2020
- Recall Number
- Z-0642-2013
- Quantity
- 201,598
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
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).