“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.
Serial Numbers: 14511,16997, 15104 Medtronic: 15140,15108, 15084, 15081, 21380, 21375, 15153, 15107, 15118, 15098, 15092, 15071, 21372, 21389, 21386 Manufactured after January 21, 2010 and prior to March 22, 2010.
Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.
Description du dispositif
microTargeting Drive System with Mounted Accessories || Catalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) || Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
Nationwide Distribution including states of CO, FL, NC and NM.
Description du dispositif
FHC microTargeting Platform DBS Measuring Fixture, || a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). || The device is a stereotactic instrument used for the placement of recording and stimulating electrodes in the brain.
microTargeting Depth Stop AdapterProduct Model Number: 66-AC-DS(1.8)microTargeting STar Drive System (Manual)Product Numbers: ST-DS-MA and 70-ZD-MAmicroTargeting STar Drive System (Motorised)Product Numbers: ST-DS-ME and 70-ZD-MEmicroTargeting Drive SystemProduct Numbers: FC1006 and 9033G0601microTargeting STar Drive System (Manual)Product Number: FC8001ARTG Number: 177545(Emergo Asia Pacific Emergo Australia - Stereotactic surgery system, neurological)