LIFEPAK 12 DEFIBRILLATOR/MONITOR

Manufacturer

  • Manufacturer Address
    BRAMPTON
  • 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
    HC

13 devices with a similar name

Learn more about the data here

  • Model / Serial
    LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544.  SERIAL NUMBERS OF DEVICES:  32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.
  • Product Description
    LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. || The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). || The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
  • Manufacturer
  • Model / Serial
    Model Catalog: 43400-XXXXXX (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 99400-XXXXXX (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    LIFEPAK 12 DEFIBRILLATOR/MONITOR
  • Manufacturer
  • Model / Serial
    Model Catalog: (Lot serial: 13940327); Model Catalog: (Lot serial: VARIOUS S/N'S)
  • Product Description
    LP12 MONOPHASIC
  • Manufacturer
  • Model / Serial
    Model Catalog: LP12 (Lot serial: SN 35489447); Model Catalog: 70402 (Lot serial: >100 NUMBERS CONTACT MFR)
  • Product Description
    LIFEPAK 12 DEFIBRILLATOR/MONITOR
  • Manufacturer
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