Events

Recall of Device Recall Phiips Healthcare HeartStart MRx/MRxE Defibrillator/Monitor

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
    52575
  • Event Risk Class
    Class 2
  • Event Number
    Z-1795-2009
  • Event Initiated Date
    2009-07-07
  • Event Date Posted
    2009-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83387
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Automated external defibrillators (non-wearable) - Product Code mkj
  • Reason
    External transport use environments, the mechanical/electrical connection between the pads therapy cable including pads/cpr cable and the mrx/mrxe may wear at an increased rate ultimately prevent the device from sensing that the pads therapy cable is connected, or, cause the device to inappropriately identify external paddles or internal paddles when the pads therapy cable is connected.
  • Action
    Philips Healthcare issued an "Urgent - Voluntary Medical Device Correction" notice dated July 2009 providing information on the affected device, namely, how to identify the affected devices and instructions on actions to be taken. Consignees are asked to contact their local Philips representative to confirm receipt of the recall letter and to arrange for service. Contact Philips Healthcare for further questions at 1-800-722-9377.

Device

Device Recall Phiips Healthcare HeartStart MRx/MRxE Defibrillator/Monitor
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Afghanistan, Albania, Australia, Austria, Bahrain, Brazil, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libyan Arab Jamaica, Lithuania, Netherlands, New Caldonia, New Zealand, Norway, Panama, Peru, Poland, Portugal, Reunion, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom and Venezuela.
  • Product Description
    HeartStart MRx/MRxE Defibrillator/Monitor Models: M3536A (HeartStart MRx) and M3536J (HeartStart MRxE). Note: M3536JIMRxE was sold to Japan only. || The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED).
  • 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