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

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: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: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-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: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

Product: drug manufacturing facilityRead More

FDA issued the draft guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” June 7, 2018. Note that there are a variety of types of Q-submissions and they do not need to be tied to a specific planned 510(k) or other premarket submission. Also note that they are not meant to...Read More

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Company:NordicNeuroLab AS Date of Enforcement Report 6/6/2018 Class lI: PRODUCT nordicBrainEXProduct Usage:nordicBrainEx 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 of medical...Read More

Company:NordicNeuroLab AS Date of Enforcement Report 6/6/2018 Class lI: PRODUCT nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians. Recall Number: Z-2044-2018 REASON An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or...Read More

Company:NordicNeuroLab AS Date of Enforcement Report 6/6/2018 Class lI: PRODUCT nordicTumorEx 1.0nordicTumorEx 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 of medical...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/62018 Class lI: PRODUCT SOMATOM Go.Now, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans. Recall Number: Z-1939-2018 REASON There is a potential for a software issue that may cause the need for necessary patient...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/62018 Class lI: PRODUCT SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans. Recall Number: Z-1940-2018 REASON There is a potential for a software issue that may cause the need for necessary patient...Read More

FDA Issued a Proposed Order to Down-Classify Certain Radiological Medical Image Analyzers, which include computer-assisted detection devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices, from class III to class II devices.  If finalized, this proposed order will reclassify computer-assisted detection devices for certain radiological applications from...Read More

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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/30/2018 Class lI: PRODUCT Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system Recall Number: Z-1930-2018 REASON Possibility that the Biograph Horizon systems performing CT retrospective...Read More

Company:Baxter Healthcare CorporationDate of Enforcement Report 5/30/2018 Class lI: PRODUCT Prismaflex 7.20 US: The Prismaflex Control Unit is intended for: ” Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. ” Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases...Read More

Company:Baxter Healthcare CorporationDate of Enforcement Report 5/30/2018 Class lI: PRODUCT Prismaflex 7.XX ROW, Product Code 114870: The Prismaflex Control Unit is intended for: ” Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. ” Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or...Read More

Company:Baxter Healthcare CorporationDate of Enforcement Report 5/30/2018 Class lI: PRODUCT Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: ” Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. ” Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms...Read More

Product: drug manufacturing facilityRead More

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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/23/2018 Class lI: PRODUCT SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system Recall Number: Z-1745-2018 REASON There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types...Read More

Company:Invivo Corporation Date of Enforcement Report 5/23/2018 Class lI: PRODUCT PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only)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-1867-2018 REASON The real-time numeric value for...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/23/2018 Class lI: PRODUCT SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system Recall Number: Z-1748-2018 REASON There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM...Read More

Company:Draegar Medical Systems, Inc. Date of Enforcement Report 5/23/2018 Class lI: PRODUCT Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained...Read More

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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/16/2018 Class lI: PRODUCT ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.. Recall Number: Z-1200-2018 REASON The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment. RECALLING FIRM/MANUFACTURER Siemens Medical...Read More

Company:Inpeco S.A. Date of Enforcement Report 5/16/2018 Class lI: PRODUCT FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System Recall Number: Z-1798-2018 REASON Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients RECALLING FIRM/MANUFACTURER Inpeco S.A....Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/16/2018 Class lI: PRODUCT Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/16/2018 Class lI: PRODUCT Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also...Read More

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