Day

June 3, 2015
Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. Recall Number...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. Recall Number...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to...
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Company: RAYSEARCH LABORATORIES AB. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1647-2015 REASON The firm was informed that while raising the patient...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1657-2015 REASON The firm was informed that while raising the patient couch on...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1656-2015 REASON The firm was informed that while raising the patient couch on...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1648-2015 REASON The firm was informed that while raising the...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1649-2015 REASON The firm was informed that while raising the patient couch...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1655-2015 REASON The firm was informed that while raising the patient...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 40. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1650-2015 REASON The firm was informed that while raising the patient couch...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1651-2015 REASON The firm was informed that while raising the patient...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-1654-2015 REASON The firm was informed that while raising the patient...
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Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area....
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Company: Medtronic Neuromodulation Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a...
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Company: Elekta Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Recall Number Z-1712-2015 REASON Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. RECALLING FIRM/MANUFACTURER...
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