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Company:Invivo Corporation. Date of Enforcement Report 6/13/2018 Class lI: PRODUCT Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Recall Number: Z-2115-2018 REASON While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control...Read More

Company:NordicNeuroLab AS Date of Enforcement Report 6/13/2018 Class lI: PRODUCT nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis...Read More

Company:NordicNeuroLab AS Date of Enforcement Report 6/13/2018 Class lI: PRODUCT nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.. Recall Number: Z-2050-2018 REASON An error was discovered in the interpretation of certain DICOM header tags that may lead to...Read More

Company:GE Healthcare Date of Enforcement Report 6/13/2018 Class lI: PRODUCT Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks...Read More

Company:Draeger Medical Systems, Inc. Date of Enforcement Report 6/13/2018 Class l: PRODUCT Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of...Read More

Company:Draeger Medical Systems, Inc. Date of Enforcement Report 6/13/2018 Class l: PRODUCT Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of...Read More

Company:Ion Beam Applications S.A.. Date of Enforcement Report 6/13/2018 Class lI: PRODUCT 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system. Recall...Read More