Day

October 7, 2014
Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens Ysio Max system The Ysio Max is 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...
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Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens Uroskop Omnia Max system The Uroskop Omnia is 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...
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Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as 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...
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Company: Siemens Healthcare DiagnosticsDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be...
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Company: Siemens Healthcare DiagnosticsDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based...
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Company: Philips Medical Systems (Cleveland) IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are 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. This device may include signal analysis and...
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Company: Baxter Healthcare Corp..Date of Enforcement Report:10/7/2014 Class lI: PRODUCT SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids. Recall Number Z-2738-2014 REASON One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014....
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