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There have been three complaints, but no deaths or injuries reported due to the software error with Zimmer Biomet’s Rosa One 3.1 Brain Application, the FDA says. Read More
Medtronic has issued a warning to healthcare providers that its Model B35200 Percept PC implantable neurostimulator might fail following a cardioversion procedure for treatment of cardiac arrhythmia. Read More
Use of the needles could result in inflammatory reactions, including systemic reactions that may lead to permanent impairment or death, the agency said. Read More
At this time, 187 software installations that automate testing with Abbott Molecular’s Alinity COVID-19 test kits are being corrected to deal with the possibility of false positive results. Read More