“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.
Software version V 3.0 and earlier. Part Number Part Description CS08651, Capnostream20 with Nellcor pulse oximetry module CS08653 Capnostream20 with Masimo pulse oximetry module CS08657 Capnostream20 with Nellcor pulse oximetry module and printer CS08659 Capnostream20 with Masimo pulse oximetry module and printer