Philips

  • Model / Serial
    Al lot codes
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.
  • Product Description
    Philips HEARTSTART Multifunction Electrode Pads || Part Number: M3718A
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Covidien LLC, 15 Hampshire St, Mansfield MA 02048-1113
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

939 devices with a similar name

Learn more about the data here

  • Model / Serial
    GEMINI TF 16 PET/CT and GEMINI TF 64 PET/CT
  • Product Description
    Positron emission tomography technology and x-ray computed tomography.
  • Manufacturer
934 more