amplia mri crt-d surescan and claria mri crt-d surescan


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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.
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  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan
  • Manufacturer
  • Modelo / Serial
    Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan Amplia MRI CRT-D SureScan/Amplia MRI Quad CRT-D SureScanModels: DTMB2D1, DTMB2D4, DTMB2QQClaria MRI CRT-D SureScan/ Claria MRI Quad CRT-D SureScan Models: DTMA2D1, DTMA2D4, DTMA2Q1, DTMA2QQMultiple ARTG numbers
  • Clasificación del producto
  • Manufacturer