Events

Recall of Device Recall Philips

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
    30666
  • Event Risk Class
    Class 2
  • Event Number
    Z-0341-05
  • Event Initiated Date
    2004-12-15
  • Event Date Posted
    2004-12-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36309
  • 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
    In software versions below a.02.00, with the sync function enabled and the device switched from manual to aed, there may be an unexpected delay in delivery of energy.
  • Action
    Philips notified customers on 12/13/04 by letter. Users are provided with action required to Mitigate Risk' until the correction is made by a Systems representative.

Device

Device Recall Philips
  • Model / Serial
    Software versions A.02.00 and lower
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign:Canada, Austria, Australlia, Belgium, China, Denmark, Finland, France, Germany, Israel, Italy,Kuwait, Latvia, Lebannon, Libya, Netherland,Norway, Portugal, Qatar, Russia, Singapore,South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand,Tunisia, UK, United Arab Emirates, Yemen
  • Product Description
    Philips Heartstart MRx Monitor/Defibrillator || Models: M3535A (Hospital Use) , M3536A (EMS Use)
  • Manufacturer
    Philips Medical Systems

Manufacturer

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