Events

Recall of Device Recall HEARTSTART MRX, MODEL M3535A

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
    52990
  • Event Risk Class
    Class 2
  • Event Number
    Z-0003-2010
  • Event Initiated Date
    2009-08-21
  • Event Date Posted
    2009-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84415
  • 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
    Incorrect default configuration settings, insufficient battery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from ac or dc power.
  • Action
    Philips Healthcare issued a Urgent Voluntary Medical Device Correction Notification on August 21, 2009 advising users of the problem and Customers are asked to follow the "Action to be taken by customer/user" section of the Urgent Voluntary Medical Device Correction Notification. In this section, customers are given the instructions to correct their devices. For further information or support concerning this issue, please contact Philips representative at 1-800-722-9377.

Device

Device Recall HEARTSTART MRX, MODEL M3535A
  • Model / Serial
    Serial numbers within the following range. US00533518 through US00535118.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Canada Australia, Austria, Beharin, BRUNEI DARUSSALAM,Chian,. Finland, France, Germany,Hong Kong, India, Indonesia, Ireland, Israel,Italy, Japan, Libya, Lithuania. Mexico, Nambia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, UAE, UK
  • Product Description
    HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. || The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • 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