Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and Uzbekistan.ġ A record in this database is created when a firm initiates a correction or removal action. Worldwide Distribution - US Nationwide in the U.S. For questions contact your local Brainlab Customer Support Representative. A warning label was provided to be placed on the system. The letter identified the affected product, problem and actions to be taken. Bell have partnered to offer the Airo Mobile Intraoperative CT, developed by Mobius Imaging and distributed by. Risk of unintended motion while the AIRO system is in transport mode.ĪIRO customers were issued Field Safety Notices dated June 29, 2017. Airo Mobile Intraoperative CT - Technical Animation - YouTube MLH and Dr. (182 kg).Īll units released since April 2014. The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. System, x-ray, tomography, computed - Product Code JAKĪIRO Mobile CT System, Model Number: MobiCT-32 Class 2 Device Recall Mobius Imaging AIRO CT
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