Events

Recall of Device Recall HeartStart XL

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
    38239
  • Event Risk Class
    Class 2
  • Event Number
    Z-1128-2007
  • Event Initiated Date
    2007-06-11
  • Event Date Posted
    2007-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53227
  • 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
    Defibrillator/Monitor - Product Code MKJ
  • Reason
    The ecg signal may become unusable to assess patient condition and need for therapy.
  • Action
    Philips Medical contacted accounts by letter dated June 11, 2007. Users are advised to remove product from service, if possible. If not, a back up unit should be available to use. Service reps will contact accounts to replace units.

Device

Device Recall HeartStart XL
  • Model / Serial
    Serial Numbers: US00453441 through US00453910
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Australia, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Kuwait, Macau, Poland, Portugal, Romania, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, UK, and Venezuela.
  • Product Description
    Philips Medical HeartStartXL Defibrillator/Monitor || Model : M4735A
  • Manufacturer
    Philips Medical Systems

Manufacturer

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