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June 14, 2017
Company: Nexstim PLC Date of Enforcement Report 6/14/2017 Class lI: PRODUCT NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of...
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Company: Nexstim PLC Date of Enforcement Report 6/14/2017 Class lI: PRODUCT Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. Recall Number Z-2319-2017 REASON Software defect: the NBS software may...
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Company: Circadiance LLC Date of Enforcement Report 6/14/2017 Class lI: PRODUCT SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients Recall Number Z-2250-2017 REASON Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to...
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