Events

Recall of Device Recall HeartStart FR2 automated external defibrillator (AED)

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
    55682
  • Event Risk Class
    Class 2
  • Event Number
    Z-0472-2011
  • Event Initiated Date
    2010-05-28
  • Event Date Posted
    2010-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91785
  • 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
    Failure of the voltage detector, u8 may cause the aed battery to drain more rapidly than normal or make the aed unusable.
  • Action
    Philips Medical Systems issued an Urgent Medical Device Recall letter dated May 28, 2010 identifying the affected device and actions to be taken. Customers were instructed to review their inventory for affected devices. If affected devices are found, the customer should contact Philips to arrange for a replacement device. The customer should also run a battery insertion test. If the device passes the test, the AED may remain in service until a replacement is received. For further information, contact Philips at 1 800 263-3342, option 6.

Device

Device Recall HeartStart FR2 automated external defibrillator (AED)
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Throughout the USA, and to the following countries: ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, FINLAND, FRANCE, GERMANY, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PERU, PORTUGAL, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIETNAM.
  • Product Description
    HeartStart FR2+ automated external defibrillator (AED) model: || M3861: PHILIPS brand; text prompts only on screen (NO ECG); no configurable manual charge.
  • Manufacturer
    Philips Medical Systems

Manufacturer

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