Events

Recall of Device Recall Philips Healthcare

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
    62342
  • Event Risk Class
    Class 2
  • Event Number
    Z-1986-2012
  • Event Initiated Date
    2012-06-20
  • Event Date Posted
    2012-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110296
  • 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
    Defibrillator/monitor cannot analyze an ecg report during acquisition of 12 lead ecg.
  • Action
    Philips Healthcare issued an Urgent Voluntary Medical Device Correction letter on June 20, 2012, to all affected customers. The Notification informs customers of the issue, identifies details (including models and software versions applicable) of units affected, instructions on actions to take while awaiting the correction, and identifies what action Philips plans to eliminate or remedy the issue A Philips Healthcare representative will contact customers to arrange for the updated R.03.03 software installation in all the affected devices. For questions customers were advised to call 1-800-722-9377. For questions regarding this recall call 978-687-1501.

Device

Device Recall Philips Healthcare
  • Model / Serial
    Serial Numbers: US00558452, US00558453, US00558493, US00558494, US00558539 US00558540, US00558546, US00558547, US00558569, US00558576 US00558584, US00558595, US00558596, US00558597, US00558615 US00558617, US00558618, US00558619, US00558620, US00558621 US00558625, US00558626, US00558627, US00558628, US00558629 US00558630, US00558640, US00558641, US00558642, US00558643 US00558644, US00558779, US00558780, US00558950, US00558952
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA
  • Product Description
    Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 || 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 Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA