Events

Recall of Philips Medical Systems

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
    31955
  • Event Risk Class
    Class 2
  • Event Number
    Z-0848-05
  • Event Initiated Date
    2005-04-29
  • Event Date Posted
    2005-05-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38809
  • 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
    The device may disarm and not deliver shock when performing a synchronized cardioversion.
  • Action
    Philips Medical Systems notified accounts by letter on 5/2/05. The firm provided instructions for identifying the effected devices and actions to be taken until the software is availablel for installation.

Device

Philips Medical Systems
  • Model / Serial
    Software Versions A.03.00 or lower and B.04.00 and lower
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada, Austria, Australia Bahrain, Belgium, Brazil, China, Hong Kong, India, Finland,France, Germany, Hungry, Israel, Italy, Korea, Kuwait, Latvia, Lebanon, Mexico, Namibia, Libya, Netherland, New Zealnd, Norway, Oma, Philippines, Portugal, Qatat, Russia, South Africa, Singapore Spain, Sweden, Switzerland, Tawian, Thailand, Tunisia, UK, United Arab Emirates, Yemen
  • Product Description
    Philips Medical HeartStart MRx Monitor/Defibrillator || Model: M3535A, M3536A
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810-1032
  • Source
    USFDA