Devices

Ventilator

Manufacturer

Covidien Korea Co., Ltd.
  • Manufacturer Address
    Seoul, Korea 16
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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
    KFDA

745 devices with a similar name

Learn more about the data here

Device Recall Emergency Transport Ventilator
  • Model / Serial
    All Oxylog 2000 plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • Product Description
    Emergency Transport Ventilator || Oxylog 2000 Plus Ventilator || Catalog Number: 5705080. || Volume controlled emergency and transport ventilator with pressure support.
  • Manufacturer
    Draeger Medical, Inc.
Device Recall Emergency Transport Ventilator
  • Model / Serial
    All Oxylog 3000 Ventilators and Oxylog 3000 Plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • Product Description
    Emergency Transport Ventilator || Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator || Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. || Volume controlled and pressure-controlled emergency and transport ventilators.
  • Manufacturer
    Draeger Medical, Inc.
Device Recall Puritan Bennett 980 Ventilator System
  • Model / Serial
    all versions of software.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including but not limited to the territory of Puerto Rico; and Ireland, Jordan, Saudi Arabia, Bahrain, Australia, Japan, Israel, Turkey, Chile, South Africa, Costa Rica, United Arab Emirates, Qatar, Peru, Panama, Singapore, Kuwait, Lebanon, Brazil, Mexico, Colombia, Russia, Uruguay, Slovenia, Morocco, Argentina, Egypt, and Romania.
  • Product Description
    Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). || Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
  • Manufacturer
    Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Device Recall Ventilator, continuous, lifesupporting; Ventilator, continuous, facility use
  • Model / Serial
    11 digit S/N begginning with GV or TV; also TGY1D01463
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.
  • Product Description
    Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, || Trilogy EC, Garbin, Garbin Plus || Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
  • Manufacturer
    Philips Respironics
Device Recall Critical Care Ventilator
  • Model / Serial
    Catalog #s 8416400 and 8417400
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including Puerto Rico.
  • Product Description
    Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. || Ventilation.
  • Manufacturer
    Draeger Medical, Inc.
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