GENIUS CARDIAC ABLATION SYSTEM - MULTI-CHANNEL RF ABLATION GENERATOR

  • Model / Serial
    Model Catalog: 990018 (Lot serial: 2011003252); Model Catalog: 990018 (Lot serial: 2010145147); Model Catalog: 990018 (Lot serial: 2010145145); Model Catalog: 990018 (Lot serial: 2010004137); Model Catalog: 990018 (Lot serial: 2010004165); Model Catalog: 990018 (Lot serial: 2010145134); Model Catalog: 990018 (Lot serial: 2010145144); Model Catalog: 990018 (Lot serial: 2010004164); Model Catalog: 990018 (Lot serial: 2011003251); Model Catalog: 990018 (Lot serial: 2010004105)
  • Product Description
    GENius Multi-Channel RF Ablation Generator
  • Manufacturer
  • 1 Event

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

One device with a similar name

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  • Model / Serial
    Model Catalog: 990018 (Lot serial: 2010145145 2010004164); Model Catalog: 990018 (Lot serial: 2010145134 2010004105); Model Catalog: 990018 (Lot serial: S/N'S 2010004165 2010145144); Model Catalog: 990018 (Lot serial: 2010004137 2010145147)
  • Product Description
    GENIUS CARDIAC ABLATION SYSTEM
  • Manufacturer