Events

Recall of Device Recall HeartStart MRx Monitor/Defibrillator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

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
    79982
  • Event Risk Class
    Class 2
  • Event Number
    Z-2035-2018
  • Event Initiated Date
    2018-05-03
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164128
  • 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 mrx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. failure to charge could potentially cause therapy to be interrupted or delayed.
  • Action
    On May 3, 2018, the firm issued an Urgent Amended Medical Device Correction notice to affected customers via certified mail. Customers were reminded that they were previously notified in April 2016 regarding the same issue. At that time, the firm committed to providing a replacement for all affected MRx units. The May 2018 notification was sent only to remaining customers who had not yet received a replacement device. Those customers were informed that due to the product being discontinued, their affected units would receive a replacement therapy board instead of a replacement unit. Customers were informed that they could continue to use their MRx prior to repair. But, if they observe a red X in the Ready for Use indicator, to follow the troubleshooting instructions in the MRx IFU. They were also advised that they would be contacted by Philips to schedule the repair of the device. If the customer has already returned their unit but has not yet received a replacement, they were advised that Philips will be replacing the therapy board, not the entire device. If you need further information or support concerning this notification, please contact your local Philips representative or call the firm at 1-800-722- 9377.

Device

Device Recall HeartStart MRx Monitor/Defibrillator
  • Model / Serial
    US00588464, US00588657, US00589878, US00591080, US00593861
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.
  • Product Description
    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) || Product Automated external defibrillators (non-wearable) || Product Usage: || The HeartStart MRx 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 in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA