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December 27, 2017
Company:Invivo CorporationDate of Enforcement Report 12/27/2017 Class lI: PRODUCT Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.. Recall Number Z-0263-2018 REASON Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results....
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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