Events

Recall of Device Recall Philips M8102A IntelliVue MP2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare 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
    56646
  • Event Risk Class
    Class 2
  • Event Number
    Z-2626-2010
  • Event Initiated Date
    2010-08-31
  • Event Date Posted
    2010-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94173
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • Reason
    Speakers on the philips intellivue x2 and mp2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment.
  • Action
    Philips issued a URGENT - MEDICAL DEVICE letter dated August 26, 2010, to each affected customer. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue and gives instructions on actions to take while awaiting their replacement speaker assemblies. The speaker replacement assembly is expected to be available in 8 weeks. Affected products may continue to e used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP at power-up. If you experience this INOP or there is no sound from your X2/MP2 speaker while it is not connected to another audible alarm annunciation system, remove the device from use and contact your local Philips service representative at 1-800-722-9377.

Device

Device Recall Philips M8102A IntelliVue MP2
  • Model / Serial
    Serial Number range: DE83604981 - DE95008299
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of : ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CHINA CZECH REPUBLIC DENMARK EGYPT ESTONIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KUWAIT LATVIA LIBYAN ARAB JAMAHIRI LITHUANIA MALAYSIA MAURITIUS MEXICO MOROCCO NAMIBIA NETHERLANDS NEW ZEALAND NORWAY OMAN PAKISTAN PALESTINE PARAGUAY POLAND PORTUGAL QATAR ROMANIA RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN THAILAND TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN and VIET NAM
  • Product Description
    Philips M8102A IntelliVue MP2 || Model: 865040 || Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment. ST segment monitoring is restricted to adult patients only. The M3002A and M8102A are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA