Events

Recall of HeartStart MRx 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
    51673
  • Event Risk Class
    Class 2
  • Event Number
    Z-1390-2009
  • Event Initiated Date
    2009-04-10
  • Event Date Posted
    2009-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80929
  • 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
    Spontaneous turn-on which could deplete the battery, rendering the device unusable until power is restored. there is also the possibility of a failure mode in which the device fails to respond to user initiated turn-on, rendering it unusable for monitoring and therapy.
  • Action
    Philips notified customers via Urgent Medical Device Recall Letter & Notice dated March 2009. Customers are asked to follow the "Actions to be taken by customer/user section of the Urgent Medical Device Recall Notice. In this section, customers are given the following instructions: "During the interim period, as you await the upgrade for your device, you may continue to use the Heartstart MRx. However, to reduce the risk that a spontaneous turn-on could deplete the battery, it is advised that you keep: a charged spare battery with the Heartstart MRx AC power applied, if possible, when the device is not in use You should also consider identifying a readily available backup defibrillator to use in the unlikely event that the device fails to turn on. Devices that exhibit a spontaneous turn-on or failure to respond to user initiated turn on should be removed from service as soon as possible." Philips will replace the therapy switch in affected units free of charge per Mandatory Field Change Order FC086100077. All customers will be contacted by a Philips Healthcare representative to arrange for replacement of the therapy switch in the affected devices.

Device

HeartStart MRx Defibrillator/Monitor
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Afghanistan, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Oman, Panama, Papua, New Guinea, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudia Arabia, Serbia & Montenegro, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    HeartStart MRx Defibrillator/Monitor, M3535A/M3536A || Is used 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