Events

Recall of Device Recall Philips HeartStart MRx Monitor/Defribillator

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

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
    67487
  • Event Risk Class
    Class 2
  • Event Number
    Z-1118-2014
  • Event Initiated Date
    2014-02-18
  • Event Date Posted
    2014-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125539
  • 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
    Ecg trunk cable and connector block of the mrx could be susceptible to accelerated wear, which could result in an interrupted ecg signal.
  • Action
    Philips Healthcare issued Urgent Medical Device Correction notification/Field Safety Notice on 2/18/14 informs customers of the issue and identifies what action Philips plans to take to remedy the issue. Philips will perform a hardware upgrade free of charge. Philips is asking customers to follow theAction to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: You can continue to use your MRx prior to receiving the hardware upgrade, while remaining aware that if the problem were to occur you could experience the following symptoms: Loss of demand mode pacing, nability to perform synchronized cardioversion with paddle andDisruption of ECG monitoring or INOP messages. Not every serial number within the listed range is affected by this Medical Device Correction. If you have questions about whether your MRx is affected by this issue, please contact Philips at 1-800-722-9377.

Device

Device Recall Philips HeartStart MRx Monitor/Defribillator
  • Model / Serial
    Serial numbers within the range:  US00100100 through US00550668
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PANAMA PAPUA NEW GUINEA PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN.
  • Product Description
    Philips HeartStart MRx Monitor/Defibrillator; Models: || M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. || Used for the termination of ventricular tachycardia and ventricular fibrillation.
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA