Covidien Emprint Percutaneous Antenna with Thermosphere Technology

  • Modèle / numéro de série
    UDI 10884521706583, Lot codes: S6MG005PX,S6MG008PX,S6MG012PX,S6MG019PX,S7AG001PX,S7AG006X,S7AG010X,S7AG013X,S7BG001X,S7BG003X,S7BG007X,S7BG013X,S7CG002X,S7CG005X,S7CG007X,S7CG013X,S7EG009X,S7FG003X,S7FG004X,S7FG007X
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide including PR, Canada, China
  • Description du dispositif
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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

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  • Modèle / numéro de série
  • Description du dispositif
    Medical electronics / Electromedical devices - electrotherapy
  • Manufacturer
  • Modèle / numéro de série
    UDI 10884521189539, Lots S5LG002PX,S5MG004PX,S5MG009PX,S5MG010PX,S5MG013PX,S5MG017PX,S5MG019PX,S6AG002X,S6AG003X,S6AG006X,S6AG009X,S6AG010X,S6BG001X,S6BG006X,S6BG012X,S6BG013X,S6BG014PX,S6CG001X,S6CG004X,S6CG006X,S6CG007X,S6CG009X,S6CG013X,S6CG018X,S6CG019X,S6DG001X,S6DG003X,S6DG006X,S6DG008X,S6DG009X,S6EG002X,S6EG003X,S6EG005X,S6EG007X,S6EG010X,S6FG002X,S6FG003X,S6FG004X,S6FG009X,S6GG004X,S6GG005X,S6GG006X,S6GG008X,S6GG009X,S6GG011X,S6GG012X,S6GG015X,S6HG002X,S6HG010X,S6HG011X,S6HG013X,S6KG001X,S6KG004PRX,S6KG004PX,S6KG007X,S6KG008X,S6KG010X,S6KG014X,S6KG015X,S6KG017X,S6LG001X,S6LG003X,S6LG005X,S6LG006X,S6LG008X,S6LG009X,S6LG010X,S6MG001X,S6MG004X,S6MG017X,S7AG004X,S7BG002X,S7BG011PCX,S7CG009PCX,S7CG012PCX,S7CG016X,S7DG001X,S7DG006X,S7EG002X,S7EG004X,S7EG005X,S7FG009PX,S7GG001X
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide including PR, Canada, China
  • Description du dispositif
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
  • Manufacturer
  • Modèle / numéro de série
    UDI 10884521189546, Lot codes: S5LG003PX,S5MG016PX,S5MG018PX,S6AG004X,S6AG005X,S6AG007X,S6BG004X,S6BG011X,S6BG015PX,S6BG017X,S6CG002X,S6CG008X,S6CG014X,S6CG015X,S6CG016X,S6DG002X,S6DG005X,S6DG007X,S6DG010X,S6EG004X,S6EG006X,S6EG008X,S6FG005X,S6FG008X,S6GG007X,S6GG010X,S6HG001X,S6HG003PX,S6HG008PX,S6HG009PX,S6HG012X,S6JG001X,S6KG003X,S6KG005PRX,S6KG005PX,S6KG009X,S6KG016X,S6LG002X,S6MG003X,S6MG018X,S7AG003X,S7BG012PCX,S7CG004X,S7CG006X,S7CG008PCX,S7CG010PCX,S7CG017X,S7DG002X,S7DG005X,S7EG006X,S7FG010PX
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide including PR, Canada, China
  • Description du dispositif
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
  • Manufacturer
  • Modèle / numéro de série
    UDI 10884521706590, Lot codes: S6MG006PX,S6MG009PX,S6MG013PX,S6MG020PX,S7AG011X,S7AG012X,S7BG008X,S7CG003X,S7DG003X,S7DG009X,S7FG001X,S7FG002X,S7FG005X,S7FG008X
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide including PR, Canada, China
  • Description du dispositif
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
  • Manufacturer
  • Modèle / numéro de série
    UDI 10884521189553, Lot codes: S5LG004PX,S6AG001X,S6BG002X,S6BG005X,S6BG016PX,S6CG003X,S6CG005X,S6CG017X,S6DG004X,S6EG001X,S6FG001X,S6FG006X,S6FG010X,S6KG002X,S6KG006PRX,S6KG006PX,S6LG004X,S6MG002X,S7CG001PCX,S7CG011PCX,S7CG015CX,S7EG001X,S7EG003X,S7FG011PX
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide including PR, Canada, China
  • Description du dispositif
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
  • Manufacturer
2 en plus