Events

Recall of Philips HeartStart FR2 AED with Text Display , Model M3861

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

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
    56816
  • Event Risk Class
    Class 2
  • Event Number
    Z-0484-2011
  • Event Initiated Date
    2010-09-22
  • Event Date Posted
    2010-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95495
  • 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
    automatic external defibrillator - Product Code MKJ
  • Reason
    A flash memory component in the heartstart fr2+ and automated external defibrillator was improperly relabeled by a third party. therefore the component could not be identified by its source, quality, and date of manufacture.
  • Action
    On 10/5/10, Philips began sending out the Voluntary Medical Device Removal notification letter to their consignees. This letter informs the consignees that Philips Healthcare is conducting a voluntary product removal of a limited number of HeartStartFR2+ automated external defibrillators (AEDs), model numbers M3860A, M3861A, M3849A, and M3841A, manufactured by Philips and shipped between March 2007 and August 2010. The owners of affected AEDs are advised to run a battery insertion test. If it passes, the AED should remain in service until its replacement is received. Philips will be replacing affected units. The consignees can visit the firm's website www.philips.com/FR2AEDAction or contact Philips at 1-800-263-3342 for any information or support concerning the issue.

Device

Philips HeartStart FR2 AED with Text Display , Model M3861
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Devices were distributed to hospitals, medical facilities, and distributors through out the US and to foreign consignees. Foreign consignees including countries: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Ecuador, El Salvador, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Guatemala, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Japan, Jordan, Kampuchea, Kenya, Korea, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Malta & Gozo, Mexico, Netherland, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom, Vietnam, and Zimbabwe.
  • Product Description
    HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurable manual charge. || The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 2301 5th Ave Ste 200, Seattle WA 98121
  • Source
    USFDA