Events

Recall of Philips Medical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems.

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
    27134
  • Event Risk Class
    Class 2
  • Event Number
    Z-1226-03
  • Event Initiated Date
    2003-09-02
  • Event Date Posted
    2003-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29254
  • 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
    Instructions for use include addtional information on configuration for selecting power on lead.
  • Action
    Philips Medical in conjunction with NNC (National Notification Center) notified users by letter on 9/2/03. Users are provided with Addendum to the HeartStart XL Instructions for Use (to be added to the Instruction for Use) and to familiarize with the configurable Power on Lead. Users are rquested to acknowledge receipt by returning the Business reply Card.

Device

Philips Medical
  • Model / Serial
    Units with software versions A.02.00 or greater
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    NATIONWIDE Foreign: Canada, Argentina, Brazil, Chile, Costa Rica, Mexico, Paraguay, Peru, Venezuela, Austalia, China,Hong Kong, India, Japan, Malaysia, Manilla, New Zealand, Manila, Singapore,Taiwan,Thailand, Vietnam, ALgeria, Australia,France,Italy, Netherlands,Norway,Oman,Poland, Portugal,South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tunisia, Turkey, UK
  • Product Description
    Model M4735A HeartStart XL Defibrillator//Monitor
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA