Events

Recall of Device Recall Philipe 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
    34045
  • Event Risk Class
    Class 3
  • Event Number
    Z-0321-06
  • Event Initiated Date
    2005-11-18
  • Event Date Posted
    2005-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42988
  • 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
    Electrode, Electrocardiograph, Multi-Function - Product Code MLN
  • Reason
    The apex/anterior and the sternum/posterior pad labels are located in reverse position to the wire and connector.
  • Action
    Philips Medical sent the recall notification letter 11/30/05 via FedEx

Device

Device Recall Philipe Medical
  • Model / Serial
    Lot Number : Y042005-1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Australia, Canada, France, germany, Spain,, Sweden, Switzerland, UK
  • Product Description
    HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads || Model M3717A
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810-1032
  • Source
    USFDA