Covidien Emprint Percutaneous Antennas with Thermosphere Technology
Modèle / numéro de série
Covidien Emprint Percutaneous Antennas with Thermosphere TechnologyEmprint Percutaneous Antenna with Thermosphere Technology, Short (15cm)Item Code: CA15L1Emprint Percutaneous Antenna with Thermosphere Technology, Standard (20cm)Item Code: CA20L1Emprint Percutaneous Antenna with Thermosphere Technology, Long (30cm)Item Code: CA30L1Lot Numbers beginning with S5L through S7GExpiration: November 2017 through July 2019ARTG Number: 178369
“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.