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 Medical Systems, 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
    67857
  • Event Risk Class
    Class 2
  • Event Number
    Z-1439-2014
  • Event Initiated Date
    2014-03-31
  • Event Date Posted
    2014-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126503
  • 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
    A component on the heartstart xl+ therapy board could malfunction potentially affecting the ability to deliver therapy.
  • Action
    Philips Healthcare issued an Urgent-Medical Device Correction letter dated March 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer/user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem. A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy. Please see the attached Field Safety Notice that provides information on how to identify affected devices and instructions on actions to be taken. Please follow the ACTION TO BE TAKEN BY CUSTOMER / USER section of the notice. To correct this issue Philips will provide a replacement therapy board to customers with affected units free of charge. This voluntary correction has been reported to the appropriate regulatory agencies. If you need any further information or support concerning this issue, please contact your local Philips representative at Philips representative contact details to be completed by the KM / country. Philips apologizes for any inconveniences caused by this problem. Further questions please call (978) 687-1501.

Device

Device Recall Philips Healthcare
  • Model / Serial
    Serial Numbers: USN1307680 USD1309181 USD1308456 USD1309182 USD1309167 USD1309184 USD1309168 USD1309194 USD1309180 USD1309195 USD1309196 USD1309274 USD1309197 USD1309286 USD1309227 USD1309301 USD1309264 US11409686 USD1309269
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of IN and WA., and the countries of : CHINA FRANCE GERMANY ITALY MALAYSIA PANAMA SAUDI ARABIA TURKEY and UNITED KINGDOM.
  • Product Description
    Philips HeartStart XL+ Defibrillator/Monitor || Model number: 861290, automatic external defibrillator.
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA