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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: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: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