Events

Recall of Device Recall Philips HeartStart FRx 861304 Automated External Defibrillator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems North America Co. Phillips.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63030
  • Event Risk Class
    Class 2
  • Event Number
    Z-0642-2013
  • Event Initiated Date
    2012-07-26
  • Event Date Posted
    2013-01-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112328
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    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.
  • 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).

Device

Device Recall Philips HeartStart FRx 861304 Automated External Defibrillator
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.
  • 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.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA